CompletedPhase 1Results posted
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
A PHASE 1, OPEN-LABEL, TWO-PART STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ATORVASTATIN AND MIDAZOLAM IN HEALTHY ADULTS AND AN ORAL CONTRACEPTIVE IN HEALTHY POST-MENOPAUSAL FEMALES
Lead sponsor
Asset
Danuglipron
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
35
Study population
Healthy volunteers
Eligibility highlights
•BMI 20-30•Healthy volunteers
Primary endpoints
•(Part A) AUC From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4•(Part A) AUCinf of Midazolam in Periods 2, 5, and 8•(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT05093205
Org study IDC3421047
Timeline
Milestones
Study start2021-10-25actual
Study first posted2021-10-26actual
Primary completion2022-07-06actual
Study completion2022-07-06actual
Last update posted2024-08-19actual
Results first posted2024-08-19actual
Assets
Investigational agents
Who this study enrolls
Healthy volunteers
Who can enroll
Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted
Inclusion criteria
•Part A Only - Healthy male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12 lead ECG and clinical laboratory tests).
•Part B Only - Healthy PM female participants between 40 and 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including BP and PR measurement, standard 12 lead ECG and clinical laboratory tests). Subjects must be amenorrheic for at least 12 months. Women who are 60 years of age or younger must also have an FSH that is within the laboratory's reference range for PM women.
•Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
•BMI- 20.0 kg/m2 to <30.0 kg/m2 at Screening.
•Stable body weight, defined as <5 % change (per participant report) for 90 days before Screening.
•Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
•Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency).
•Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
•Known intolerance or hypersensitivity to GLP-1R agonists.
•Known hypersensitivity to atorvastatin or midazolam (for participants in Part A), or LE and EE (for participants in Part B).
•Personal or family history of MTC or MEN2 or study participants with suspected MTC per the investigator's judgment.
•Symptomatic gallbladder disease.
•History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years from screening.
•Any lifetime history of a suicide attempt.
•Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
•Systemic therapy with any of the medications that are moderate or strong CYP3A4/5, CYP2C9 and/or CYP2C19 inhibitors within 28 days or 5 half-lives (whichever is longer) or moderate or strong CYP3A, CYP2C9 and/or CYP2C19 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
•Systemic therapy with inhibitors of the BCRP transporter within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
•Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
•Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
•Known prior participation in a trial involving PF-06882961.
•A PHQ-9 score ≥15 obtained at Screening or Day -1 in Study.
•Response of "yes" to question 4 or 5, or on any suicidal behavioral question on the C SSRS at Screening or Day -1 in Study.
•A positive urine drug test.
•Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. BP should be measured in triplicate and the average of the 3 BP values should be used to determine the participant's eligibility. Note: At screening, the participant's arm circumference should be measured (eg, using a flexible anthropometric tape) at the midpoint of the length of the upper arm and the appropriate cuff selected and used throughout the study.
•Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
•Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
-HbA1c ≥6.5%.
-Aspartate AST or ALT level ≥2 times the ULN.
-Total bilirubin level ≥1.5 times the ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
-TSH >1.5x the ULN or <LLN.
-Serum calcitonin > the ULN.
-Amylase or lipase > the ULN.
-Fasting blood glucose ≥126 mg/dL.
-Fasting C-peptide <0.8 ng/mL.
-eGFR <70 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
-Positive testing for HIV, HepBsAg, or HCVAb. Study participants positive for HCVAb are to be excluded unless known to have been treated with a known curative therapy and negative for HCV RNA. Hepatitis B vaccination is allowed.
-A positive SARS-CoV-2 test.
•Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
•History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
•Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
•Known or suspected illicit drug use.
•Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing randomization (Day-1).
•History of sensitivity to heparin or heparin induced thrombocytopenia if Hep-lock is used for IV blood draw.
•Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
•Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Endpoints (36)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
29
Weight & body composition
4
Patient-reported / QoL
3
Weight & body composition
4 endpointsSecondary/registry result
(Part A) Percentage of Change From Baseline in Body Weight
Time frame:Percentage of change from Baseline 1: from the last pre-dose measurement in Part A Period 1 (ie, Baseline 1) to Day 2 of Part A Period 8; percentage of Change from the last predose measurement in Part A Period 3 (ie, Baseline 2) to Day 2 of Period 8.
change from baseline, improvement
Posted result
| Group | Mean · percentage | 95% CI |
|---|---|---|
| All Participants in Part ABaseline 1 - Period 8 Day 2 / PF-06882961 200 mg BID + Midazolam 5 mg | -9.04 | - |
| Baseline 2 - Period 8 Day 2 / PF-06882961 200 mg BID + Midazolam 5 mg | -9.30 | - |
Secondary/registry result
(Part B) Percentage of Change From Baseline in Body Weight
Time frame:Percentage of Change from Baseline 1:from the last pre-dose measurement in Part B Period 1 (ie, Baseline 1) to Day 2 of Part B Period 8;percentage of Change from the last predose measurement in Part B Period 2 (ie, Baseline 2) to Day 6 of Part B Period 5.
change from baseline, improvement
Posted result
| Group | Mean · percentage | 95% CI |
|---|---|---|
| All Participants in Part BBaseline 1 - Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE | -8.77 | - |
| Baseline 2 - Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE | -5.40 | - |
Secondary/protocol endpoint
(Part A) Percentage of Change From Baseline in Body Weight
Time frame:Percentage of change from Baseline 1: from the last pre-dose measurement in Part A Period 1 (ie, Baseline 1) to Day 2 of Part A Period 8; percentage of Change from the last predose measurement in Part A Period 3 (ie, Baseline 2) to Day 2 of Period 8.
Body weight, % change
percent change from baseline, improvement
Secondary/protocol endpoint
(Part B) Percentage of Change From Baseline in Body Weight
Time frame:Percentage of Change from Baseline 1:from the last pre-dose measurement in Part B Period 1 (ie, Baseline 1) to Day 2 of Part B Period 8;percentage of Change from the last predose measurement in Part B Period 2 (ie, Baseline 2) to Day 6 of Part B Period 5.
Body weight, % change
percent change from baseline, improvement
Patient-reported / QoL
3 endpointsSecondary/registry result
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| All Participants in Part APeriod 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 18 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 17 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 16 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 15 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 16 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 12 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 15 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating | 10 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating | 2 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating | 1 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 13 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 12 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 1 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 12 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 8 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 2 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 2 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 11 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 2 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 13 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 11 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 1 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 1 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 10 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 2 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 1 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 7 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 2 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 3 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 13 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 13 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 13 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 13 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 5 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 1 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 6 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 5 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 1 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 5 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 5 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 6 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 5 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 1 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 5 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 1 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 6 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself | 6 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless | 5 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless | 1 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead | 6 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead | 0 | - |
| Follow Up | 14 | - |
| Follow Up | 1 | - |
| Follow Up | 0 | - |
| Follow Up | 0 | - |
Secondary/protocol endpoint
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
categorical status, descriptive
Secondary/protocol endpoint
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.
threshold achievement, improvement
Safety / tolerability / PK
29 endpointsPrimary/registry result
(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7
Time frame:For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.
concentration, descriptive
Posted result
| Group | Geometric mean · nanogram*hour/milliliter (ng*hr/mL) | 95% CI |
|---|---|---|
| Atorvastatin 20 mg (Part A Period 1) | 32.27 | - |
| PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4) | 46.94 | - |
| PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7) | 54.43 | - |
Primary/registry result
(Part A) AUCinf of Midazolam in Periods 2, 5, and 8
Time frame:For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.
descriptive
Posted result
| Group | Geometric mean · ng*hr/mL | 95% CI |
|---|---|---|
| Midazolam 5 mg (Part A Period 2) | 70.53 | - |
| PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5) | 58.81 | - |
| PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8) | 49.78 | - |
Primary/registry result
(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5
Time frame:For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.
descriptive
Posted result
| Group | Geometric mean · picogram*hour/milliliter (pg*hr/mL) | 95% CI |
|---|---|---|
| 0.15 mg LE & 0.03 mg EE (Part B Period 1) | 48800 | - |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3) | 62330 | - |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5) | 66490 | - |
Specified in comments122.4890% CI106.96 - 140.25Mixed Models Analysis
Specified in comments143.8390% CI122.64 - 168.68Mixed Models Analysis
Primary/registry result
(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5
Time frame:For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.
descriptive
Posted result
| Group | Geometric mean · pg*hr/mL | 95% CI |
|---|---|---|
| 0.15 mg LE & 0.03 mg EE (Part B Period 1) | 772.1 | - |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3) | 723.5 | - |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5) | 604.4 | - |
Specified in comments104.4690% CI92.56 - 117.89Mixed Models Analysis
Specified in comments92.7790% CI81.05 - 106.19Mixed Models Analysis
Primary/protocol endpoint
(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7
Time frame:For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.
AUC₀-∞
concentration, descriptive
Primary/protocol endpoint
(Part A) AUCinf of Midazolam in Periods 2, 5, and 8
Time frame:For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.
AUC₀-∞
concentration, descriptive
Primary/protocol endpoint
(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5
Time frame:For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.
AUC₀-∞
concentration, descriptive
Primary/protocol endpoint
(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5
Time frame:For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.
AUC₀-∞
concentration, descriptive
Secondary/registry result
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Time frame:From Baseline up to follow-up telephone contact (Days 90-97) in Part A of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Atorvastatin 20 mg (Part A Period 1)Participants with adverse events | 2 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| Midazolam 5 mg (Part A Period 2)Participants with adverse events | 3 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| PF-06882961 Titration up to 120 mg BID (Part A Period 3)Participants with adverse events | 13 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 2 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 1 | - |
| PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)Participants with adverse events | 5 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)Participants with adverse events | 4 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| PF-06882961 Titration up to 200 mg BID (Part A Period 6)Participants with adverse events | 12 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 7 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 4 | - |
| PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)Participants with adverse events | 5 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)Participants with adverse events | 2 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 1 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
Secondary/registry result
(Part B) Number of Participants With TEAE During Part B of the Study
Time frame:From Baseline up to follow-up telephone contact (Days 94-101) in Part B of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| 0.15 mg LE & 0.03 mg EE (Part B Period 1)Participants with adverse events | 5 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| PF-06882961 Titration up to 120 mg BID (Part B Period 2)Participants with adverse events | 15 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 2 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 2 | - |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)Participants with adverse events | 7 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 2 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
| PF-06882961 Titration up to 200 mg BID (Part B Period 4)Participants with adverse events | 12 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 2 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 2 | - |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)Participants with adverse events | 7 | - |
| Participants with serious adverse events | 0 | - |
| Participants with severe adverse events | 0 | - |
| Participants discontinued from study due to AEs | 0 | - |
| Participants discontinued study drug due to AE and continue study | 0 | - |
| Participants with dose reduced or temporary discontinuation due to AE | 0 | - |
Secondary/registry result
(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)
Time frame:From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Atorvastatin 20 mg (Part A Period 1) | 0 | - |
| Midazolam 5 mg (Part A Period 2) | 15 | - |
| PF-06882961 Titration up to 120 mg BID (Part A Period 3) | 16 | - |
| PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4) | 2 | - |
| PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5) | 5 | - |
| PF-06882961 Titration up to 200 mg BID (Part A Period 6) | 12 | - |
| PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7) | 0 | - |
| PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8) | 6 | - |
Secondary/registry result
(Part B) Number of Participants With Clinical Laboratory Abnormalities During Part B of the Study (Without Regard to Baseline Abnormality)
Time frame:From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| 0.15 mg LE & 0.03 mg EE (Part B Period 1) | 17 | - |
| PF-06882961 Titration up to 120 mg BID (Period 2) | 16 | - |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3) | 2 | - |
| PF-06882961 Titration up to 200 mg BID (Part B Period 4) | 12 | - |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5) | 9 | - |
Secondary/registry result
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Time frame:From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Atorvastatin 20 mg (Part A Period 1)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 0 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| Midazolam 5 mg (Part A Period 2)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 0 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 Titration up to 120 mg BID (Part A Period 3)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 2 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 2 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 2 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 3 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 Titration up to 200 mg BID (Part A Period 6)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 2 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)Supine systolic blood pressure (SBP) value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine diastolic blood pressure (DBP) value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 1 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
Secondary/registry result
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Time frame:From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| 0.15 mg LE & 0.03 mg EE (Part B Period 1)Supine SBP value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine DBP value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 Titration up to 120 mg BID (Part B Period 2)Supine SBP value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine DBP value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 3 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)Supine SBP value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 0 | - |
| Supine DBP value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 0 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 Titration up to 200 mg BID (Part B Period 4)Supine SBP value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine DBP value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)Supine SBP value <90 mm Hg | 0 | - |
| Supine SBP change >=30 mm Hg increase | 0 | - |
| Supine SBP change >=30 mm Hg decrease | 1 | - |
| Supine DBP value <50 mm Hg | 0 | - |
| Supine DBP >= 20 mm Hg increase | 0 | - |
| Supine DBP >= 20 mm Hg decrease | 1 | - |
| Pulse rate value <40 bpm | 0 | - |
| Pulse rate value >120 bpm | 0 | - |
Secondary/registry result
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
Time frame:From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Atorvastatin 20 mg (Part A Period 1)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| Midazolam 5 mg (Part A Period 2)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 Titration up to 120 mg BID (Part A Period 3)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 1 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 2 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 Titration up to 200 mg BID (Part A Period 6)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 1 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 1 | - |
| QTcF change >60 msec | 0 | - |
Secondary/registry result
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
Time frame:From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| 0.15 mg LE & 0.03 mg EE (Part B Period 1)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 Titration up to 120 mg BID (Part B Period 2)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 Titration up to 200 mg BID (Part B Period 4)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 1 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)PR interval value >=300 msec | 0 | - |
| PR interval %change >=25/50% msec | 0 | - |
| QRS interval value >= 140 msec | 0 | - |
| QRS interval %change >=50% msec | 0 | - |
| QTcF 450 msec < value <=480 msec | 0 | - |
| QTcF 480 msec < value <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF 30 msec < change <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
Secondary/registry result
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| All Participants in Part APeriod 1 Day -1 / Atorvastatin 20 mg | 0 | - |
| Period 1 Day -1 / Atorvastatin 20 mg Past 12 Months | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 3 Day 23 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg (Since Last Visit) | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID (Since Last Visit) | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID (Since Last Visit) | 0 | - |
| Period 6 Day 19 / PF-06882961 titration up to 200 mg BID (Since Last Visit) | 0 | - |
| Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg (Since Last Visit) | 0 | - |
| Follow Up (Since Last Visit) | 0 | - |
Secondary/registry result
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| All Participants in Part BPeriod 1 Day -1 / 0.15 mg LE & 0.03 mg EE | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE (Past 12 months) | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID (Since Last Visit) | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Since Last Visit) | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID (Since Last Visit) | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID (Since Last Visit) | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID (Since Last Visit) | 0 | - |
| Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Since Last Visit) | 0 | - |
| Follow Up (Since Last Visit) | 0 | - |
Secondary/registry result
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| All Participants in Part BPeriod 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things | 17 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless | 16 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless | 1 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep | 17 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy | 16 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy | 1 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 16 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 1 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 16 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 1 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things | 17 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless | 17 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 17 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 16 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 16 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 16 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 15 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 15 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 15 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 1 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 15 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 1 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 16 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 16 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 15 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 15 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 16 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 15 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 1 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 16 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 16 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 15 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 13 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 2 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 16 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 16 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 16 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 16 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 15 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 1 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 16 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 16 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 15 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 13 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 3 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 16 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 16 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 16 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 16 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 13 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 1 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 1 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 15 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 14 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 1 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 13 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 1 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 1 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 10 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 3 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating | 2 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 15 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things | 14 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things | 1 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 14 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 1 | - |
| Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 15 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 11 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 1 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 12 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 12 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 10 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 2 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 9 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 2 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 12 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 12 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 12 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 12 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 11 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 11 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 10 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 10 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 8 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 11 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 10 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 10 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 1 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 11 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things | 9 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless | 9 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep | 8 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep | 1 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 8 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy | 1 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating | 7 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating | 1 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating | 1 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself | 9 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things | 8 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things | 1 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless | 8 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless | 1 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead | 9 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 9 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 9 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 8 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep | 1 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 8 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy | 1 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating | 7 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating | 1 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating | 1 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself | 9 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things | 8 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things | 1 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 8 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 0 | - |
| Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless | 1 | - |
| Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 9 | - |
| Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead | 0 | - |
| Follow Up / Little Interest/Pleasure in Things | 11 | - |
| Follow Up / Little Interest/Pleasure in Things | 0 | - |
| Follow Up / Little Interest/Pleasure in Things | 0 | - |
| Follow Up / Little Interest/Pleasure in Things | 0 | - |
| Follow Up / Feeling Down Depressed or Hopeless | 11 | - |
| Follow Up / Feeling Down Depressed or Hopeless | 0 | - |
| Follow Up / Feeling Down Depressed or Hopeless | 0 | - |
| Follow Up / Feeling Down Depressed or Hopeless | 0 | - |
| Follow Up / Trouble Falling or Staying Asleep | 10 | - |
| Follow Up / Trouble Falling or Staying Asleep | 1 | - |
| Follow Up / Trouble Falling or Staying Asleep | 0 | - |
| Follow Up / Trouble Falling or Staying Asleep | 0 | - |
| Follow Up / Feeling Tired or Little Energy | 11 | - |
| Follow Up / Feeling Tired or Little Energy | 0 | - |
| Follow Up / Feeling Tired or Little Energy | 0 | - |
| Follow Up / Feeling Tired or Little Energy | 0 | - |
| Follow Up / Poor Appetite or Overeating | 11 | - |
| Follow Up / Poor Appetite or Overeating | 0 | - |
| Follow Up / Poor Appetite or Overeating | 0 | - |
| Follow Up / Poor Appetite or Overeating | 0 | - |
| Follow Up / Feeling Bad About Yourself | 11 | - |
| Follow Up / Feeling Bad About Yourself | 0 | - |
| Follow Up / Feeling Bad About Yourself | 0 | - |
| Follow Up / Feeling Bad About Yourself | 0 | - |
| Follow Up / Trouble Concentrating on Things | 11 | - |
| Follow Up / Trouble Concentrating on Things | 0 | - |
| Follow Up / Trouble Concentrating on Things | 0 | - |
| Follow Up / Trouble Concentrating on Things | 0 | - |
| Follow Up / Moving Slowly or Fidgety/Restless | 11 | - |
| Follow Up / Moving Slowly or Fidgety/Restless | 0 | - |
| Follow Up / Moving Slowly or Fidgety/Restless | 0 | - |
| Follow Up / Moving Slowly or Fidgety/Restless | 0 | - |
| Follow Up / Thoughts You Be Better Off Dead | 11 | - |
| Follow Up / Thoughts You Be Better Off Dead | 0 | - |
| Follow Up / Thoughts You Be Better Off Dead | 0 | - |
| Follow Up / Thoughts You Be Better Off Dead | 0 | - |
Secondary/protocol endpoint
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Time frame:From Baseline up to follow-up telephone contact (Days 90-97) in Part A of the study.
Treatment-emergent AEs (any)
event count, event
Secondary/protocol endpoint
(Part B) Number of Participants With TEAE During Part B of the Study
Time frame:From Baseline up to follow-up telephone contact (Days 94-101) in Part B of the study.
Treatment-emergent AEs (any)
event count, event
Secondary/protocol endpoint
(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)
Time frame:From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
event count, event
Secondary/protocol endpoint
(Part B) Number of Participants With Clinical Laboratory Abnormalities During Part B of the Study (Without Regard to Baseline Abnormality)
Time frame:From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
descriptive, event
Secondary/protocol endpoint
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Time frame:From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
event count, event
Secondary/protocol endpoint
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Time frame:From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
event count, event
Secondary/protocol endpoint
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
Time frame:From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
threshold achievement, event
Secondary/protocol endpoint
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
Time frame:From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
event count, event
Secondary/protocol endpoint
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
descriptive, event
Secondary/protocol endpoint
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Time frame:Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.
descriptive, event
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.