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DIADS-2

CompletedPhase 2 / PHASE3Results posted

Depression in Alzheimer's Disease-2

Depression in Alzheimer's Disease (DIADS-2)

Lead sponsor

Johns Hopkins University

Asset

Sertraline

Listed sites

Recruiting sites

Enrollment

131

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

SecondaryDATR A4-GPX

NCT IDNCT00086138

Org study IDU01MH066136https://reporter.nih.gov/quickSearch/U01MH066136

NihU01MH066136

Timeline

Milestones

Study first posted2004-06-28estimated

Study start2004-07 (month precision)

Primary completion2008-07actual (month precision)

Study completion2009-07actual (month precision)

Last update posted2017-04-11actual

Results first posted2017-04-11actual

Assets

Drug assets

Sertraline

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Inclusion:

•Ability of the participant, caregiver or surrogate to provide written informed consent.

•Dementia due to Alzheimer's disease

•Stable treatment for Alzheimer's disease

•Ability for the participant's caregiver to accompany the participant to study visits and participate in the study.

Exclusion

•Presence of a brain disease that might otherwise explain the presence of dementia

•Clinically significant hallucinations or delusions

•Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications

•Need for hospitalization or residence in a nursing facility

Endpoints (4)

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.

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)

Time frame:Measured at Week 12

change from baseline, improvement

Primary/registry result

Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)

Time frame:Measured at Week 12

change from baseline, improvement

Posted result

Group	Value (number), participants	Reported bounds
Sertraline"much worse"n=67 Participants	1	-
"worse"n=67 Participants	5	-
"a bit worse"n=67 Participants	6	-
"no change"n=67 Participants	10	-
"a bit better"n=67 Participants	18	-
"better"n=67 Participants	18	-
"much better"n=67 Participants	9	-
Placebo"much worse"n=64 Participants	0	-
"worse"n=64 Participants	2	-
"a bit worse"n=64 Participants	9	-
"no change"n=64 Participants	11	-
"a bit better"n=64 Participants	18	-
"better"n=64 Participants	21	-
"much better"n=64 Participants	3	-

Odds Ratio (OR)1.0195% CI0.52 - 1.97p0.98Chi-squared

Secondary/protocol endpoint

Remission According to Cornell Scale for Depression in Dementia Scale

Time frame:Measured at Weeks 12

descriptive

Secondary/registry result

Remission According to Cornell Scale for Depression in Dementia Scale

Time frame:Measured at Weeks 12

descriptive

Posted result

Group	Value (number), percentage of participants	Reported bounds
Sertralinen=67 Participants	33	-
Placebon=64 Participants	19	-

Odds Ratio (OR)2.0695% CI0.84 - 5.04p0.11Chi-squared

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

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 21, 2026 snapshot.