Trial · NCT00898807

Citalopram for Agitation in Alzheimer's Disease

NCT00898807, Phase 3, Completed, JHSPH Center for Clinical Trials; results first posted 2014-06-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Citalopram for Agitation in Alzheimer's Disease. Trials, record NCT00898807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00898807

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Citalopram for Agitation in Alzheimer's Disease
NCT number: NCT00898807
Status: Completed
Phases: Phase 3
Enrollment: 186 participants, actual
Lead sponsor: JHSPH Center for Clinical Trials
Conditions: Alzheimer's Disease, Agitation
Interventions: citalopram, placebo
First posted: 2009-05-12
Last updated: 2014-06-27
Results first posted: 2014-06-27

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	NeuroBehavior Rating Scale-- Agitation	9 weeks	NeuroBehavioral Rating Scale- Agitation(NBRS-A) assesses multiple types of psychopathology common in dementia and is based on a seven point Likert scale of increasing severity for each item(i.e., 0=not present, 1=very mild, 2-mild, 3=moderate, 4=moderately severe, 5=severe, 6=extremely severe). The NBRS agitation subscore includes NBRS 'inhibition', 'agitation', and 'hostility'. The range is 0 to 18 points. Higher scores indicate more symptoms.
Primary	Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)	Baseline to 9 weeks	Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in agitation(CGIC) accesses clinically significant change in agitation. A trained clinician, blind to treatment assignment, uses a 7-point Likert scale to rate change of each patient along a continuum from "marked improvement"(1), "no change"(4), and "marked worsening"(7). A number of aspects of the agitation is considered such as emotional agitation, mood liability/distress, psychomotor agitation, verbal aggression, and physical aggression. Range is 1-7.
Secondary	Cohen-Mansfield Agitation Inventory (CMAI)	9 weeks	CMAI examines several agitated behaviors including verbal, physical agitation, and other behaviors. Sub-items are summed. Range is 14-70. Higher scores indicate more severe symptoms.
Secondary	Neuropsychiatric Inventory (NPI)-- Agitation Subscore	9 weeks	NPI agitation score is based on responses from an informed caregiver involved in the patient's life. Symptom severity (1=mild, 2=moderate, 3=severe) is multiplied by frequency (1=occasionally, less than once/week; 4 = very frequently, once or more/day or continuously) to obtain the NPI agitation score.Range is 0-12. Higher scores indicate more severe symptoms.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	NeuroBehavior Rating Scale-- Agitation	9 weeks	The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on the NBRS.	units on a scale	MEAN
PRIMARY	Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)	Baseline to 9 weeks	The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on CGIC.	percentage moderate/marked improvement	NUMBER
SECONDARY	Cohen-Mansfield Agitation Inventory (CMAI)	9 weeks	The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data.	units on a scale	MEAN
SECONDARY	Neuropsychiatric Inventory (NPI)-- Agitation Subscore	9 weeks	The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
NeuroBehavior Rating Scale-- Agitation	Citalopram and Psychosocial Intervention	4.33	Standard Error 0.31	units on a scale
NeuroBehavior Rating Scale-- Agitation	Placebo and Psychosocial Intervention	5.26	Standard Error 0.31	units on a scale
Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)	Citalopram and Psychosocial Intervention	40		percentage moderate/marked improvement
Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)	Placebo and Psychosocial Intervention	26		percentage moderate/marked improvement
Cohen-Mansfield Agitation Inventory (CMAI)	Citalopram and Psychosocial Intervention	27.7	Standard Deviation 6.7	units on a scale
Cohen-Mansfield Agitation Inventory (CMAI)	Placebo and Psychosocial Intervention	28.7	Standard Deviation 6.7	units on a scale
Neuropsychiatric Inventory (NPI)-- Agitation Subscore	Citalopram and Psychosocial Intervention	7.8	Standard Deviation 2.2	units on a scale
Neuropsychiatric Inventory (NPI)-- Agitation Subscore	Placebo and Psychosocial Intervention	8.0	Standard Deviation 2.4	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Citalopram and Psychosocial Intervention	94
Overall Study	STARTED	Placebo and Psychosocial Intervention	92
Overall Study	COMPLETED	Citalopram and Psychosocial Intervention	86
Overall Study	COMPLETED	Placebo and Psychosocial Intervention	83
Overall Study	NOT COMPLETED	Citalopram and Psychosocial Intervention	8
Overall Study	NOT COMPLETED	Placebo and Psychosocial Intervention	9

Source ClinicalTrials.gov

Adverse events92

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Sweating	Nervous system disorders	Citalopram and Psychosocial Intervention	9	90
other	Sweating	Nervous system disorders	Placebo and Psychosocial Intervention	12	86
other	Tremor	Nervous system disorders	Citalopram and Psychosocial Intervention	23	90
other	Tremor	Nervous system disorders	Placebo and Psychosocial Intervention	16	86
other	Dizziness	Nervous system disorders	Citalopram and Psychosocial Intervention	22	90
other	Dizziness	Nervous system disorders	Placebo and Psychosocial Intervention	19	86
other	Gait instability	Nervous system disorders	Citalopram and Psychosocial Intervention	50	90
other	Gait instability	Nervous system disorders	Placebo and Psychosocial Intervention	44	86
other	Yawning	Nervous system disorders	Citalopram and Psychosocial Intervention	11	90
other	Yawning	Nervous system disorders	Placebo and Psychosocial Intervention	17	86

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Citalopram and Psychosocial Intervention
Total, all-cause mortality	Placebo and Psychosocial Intervention
Total, other adverse events	Citalopram and Psychosocial Intervention	90	90
Total, other adverse events	Placebo and Psychosocial Intervention	86	86
Total, serious adverse events	Citalopram and Psychosocial Intervention	8	94
Total, serious adverse events	Placebo and Psychosocial Intervention	7	92

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22301195	BACKGROUND	PubMed
24549548	RESULT	PubMed
24914549	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AG031348	Citalopram Treatment for Agitation in Alzheimer Dementia	LYKETSOS, CONSTANTINE G	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON AGING	2008 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Citalopram and Psychosocial Intervention vs Placebo and Psychosocial Intervention: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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