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Citalopram for Agitation in Alzheimer's Disease

Information source: JHSPH Center for Clinical Trials
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease; Agitation

Intervention: citalopram (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: JHSPH Center for Clinical Trials

Official(s) and/or principal investigator(s):
Constantine Lyketsos, MD, MHS, Study Chair, Affiliation: Johns Hopkins University
Lon Schneider, MD, Principal Investigator, Affiliation: University of Southern California Keck School of Medicine Memory and Aging Center
Bruce Pollock, MD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health
Jacobo Mintzer, MD, Principal Investigator, Affiliation: Medical University of South Carolina Alzheimer's Research and Clinical Programs
David Shade, Esq, Principal Investigator, Affiliation: Johns Hopkins University
Davengere Devanand, MD, Principal Investigator, Affiliation: Columbia University
Paul Rosenberg, MD, Principal Investigator, Affiliation: Johns Hopkins University
Daniel Weintraub, MD, Principal Investigator, Affiliation: University of Pennsylvania
Anton Porsteinsson, MD, Principal Investigator, Affiliation: University of Rochester
Jerome Yesavage, MD, Principal Investigator, Affiliation: Stanford University


The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

NeuroBehavior Rating Scale-- Agitation

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

Secondary outcome:

Cohen-Mansfield Agitation Inventory (CMAI)

Neuropsychiatric Inventory (NPI)-- Agitation Subscore

Detailed description: This study is designed to examine the efficacy and safety of citalopram as treatment for clinically significant agitation in Alzheimer's dementia (AD) patients. It will also investigate pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. The management of agitation is a major priority in treating patients with AD. Non-pharmacologic options have limited effectiveness. Several pharmacologic options have been explored, but findings for anticonvulsants, antipsychotics, and cholinesterase inhibitors are disappointing or associated with questionable risk-benefit ratio. Better pharmacologic options are needed. Selective serotonin reuptake inhibitors (SSRIs) show promise as a treatment for agitation in AD, based on evidence of a link between agitation and brain serotonin system abnormalities in AD patients, and on preliminary clinical data from a single-site, randomized controlled trial (RCT) in which citalopram was superior to perphenazine and placebo.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

University of Southern California Keck School of Medicine Memory and Aging Center, Los Angeles, California 90089, United States

VA Palo Alto Health Care System, Palo Alto, California 94304, United States

Johns Hopkins University, Baltimore, Maryland 21224, United States

Columbia University, New York, New York 10032, United States

Monroe Community Hospital, Rochester, New York 14559, United States

Centre for Addiction and Mental Health, Toronto, Ontario M6J1H4, Canada

University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House, Philadelphia, Pennsylvania 19104, United States

Medical University of South Carolina Alzheimer's Research and Clinical Programs, Charleston, South Carolina 29406, United States

Additional Information

Related publications:

Drye LT, Ismail Z, Porsteinsson AP, Rosenberg PB, Weintraub D, Marano C, Pelton G, Frangakis C, Rabins PV, Munro CA, Meinert CL, Devanand DP, Yesavage J, Mintzer JE, Schneider LS, Pollock BG, Lyketsos CG; CitAD Research Group. Citalopram for agitation in Alzheimer's disease: design and methods. Alzheimers Dement. 2012;8(2):121-30. doi: 10.1016/j.jalz.2011.01.007. Epub 2012 Feb 1.

Starting date: July 2009
Last updated: June 26, 2014

Page last updated: August 23, 2015

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