CitAD

CompletedPhase 3Results posted

Citalopram for Agitation in Alzheimer's Disease

A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease

Lead sponsor

JHSPH Center for Clinical Trials

Asset

Citalopram

Listed sites

Recruiting sites

Enrollment

186

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•NeuroBehavior Rating Scale-- Agitation•Modified 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

Org study IDIA0155

NCT IDNCT00898807

NihR01AG031348

Timeline

Milestones

Study first posted2009-05-12estimated

Study start2009-07 (month precision)

Primary completion2013-09actual (month precision)

Study completion2013-09actual (month precision)

Last update posted2014-06-27estimated

Results first posted2014-06-27estimated

Assets

Drug assets

Citalopram

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria), with Mini-Mental score of 5-28 inclusive

•A medication for agitation is appropriate, in the opinion of the study physician

•Clinically significant agitation for which either

1. the frequency of agitation as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or

2. the frequency of agitation as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'

•Provision of informed consent for participation in the study by patient or surrogate (if necessary) and caregiver

•Availability of primary caregiver, who spends several hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study

•No change to Alzheimer's disease (AD) medications within the month preceding randomization, including starting, stopping, or dosage modifications

Exclusion criteria

•Meets criteria for Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV (TR)) criteria

•Presence of a brain disease that might otherwise explain the presence of dementia, such as extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis

•Psychosis (delusions or hallucinations) requiring antipsychotic treatment in the opinion of the study physician

•Prolonged measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval)

•Treatment with citalopram is contraindicated in the opinion of the study physician

•Failure of past treatment with citalopram for agitation after adequate trial at a minimally accepted dose (greater than or equal to 20 mg/day)

•Treatment with a medication that would prohibit the safe concurrent use of citalopram, such as Monoamine oxidases (MAO) inhibitors

•Need for psychiatric hospitalization or suicidal

•Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes

•Current treatment with antipsychotics, anticonvulsants (other than dilantin), other antidepressants (other than trazodone, less than or equal to 50 mg per day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants

•Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the patient to enroll in the trial

Endpoints (8)

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

8 endpoints

Primary/protocol endpoint

NeuroBehavior Rating Scale-- Agitation

Time frame:9 weeks

descriptive

Primary/registry result

NeuroBehavior Rating Scale-- Agitation

Time frame:9 weeks

descriptive

Posted result

Group	Value (mean), units on a scale	Standard error
Citalopram and Psychosocial Interventionn=90 Participants	4.33	0.31
Placebo and Psychosocial Interventionn=85 Participants	5.26	0.31

Mean Difference (Net)-0.9395% CI-1.80 - -0.06p0.036Mixed Models Analysis

Primary/protocol endpoint

Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)

Time frame:Baseline to 9 weeks

change from baseline, improvement

Primary/registry result

Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)

Time frame:Baseline to 9 weeks

change from baseline, improvement

Posted result

Group	Value (number), percentage moderate/marked improvement	Reported bounds
Citalopram and Psychosocial Interventionn=86 Participants	40	-
Placebo and Psychosocial Interventionn=81 Participants	26	-

Odds Ratio (OR)2.1395% CI1.23 - 3.69p0.007Proportional odds

Secondary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:9 weeks

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)-- Agitation Subscore

Time frame:9 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:9 weeks

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Citalopram and Psychosocial Interventionn=90 Participants	27.7	6.7
Placebo and Psychosocial Interventionn=85 Participants	28.7	6.7

Secondary/registry result

Neuropsychiatric Inventory (NPI)-- Agitation Subscore

Time frame:9 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (mean), units on a scale	Standard deviation
Citalopram and Psychosocial Interventionn=90 Participants	7.8	2.2
Placebo and Psychosocial Interventionn=85 Participants	8.0	2.4

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.