Citalopram for Agitation in Alzheimer's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease, Agitation

In brief

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

Key facts

Study ID: NCT00898807
Run by: JHSPH Center for Clinical Trials
People needed: 186
Starts: 2009-07-01
Expected to finish: 2013-09-01
Last updated by the study team: 2014-06-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Southern California Keck School of Medicine Memory and Aging Center — Los Angeles, California, United States
VA Palo Alto Health Care System — Palo Alto, California, United States
Johns Hopkins University — Baltimore, Maryland, United States
Columbia University — New York, New York, United States
Monroe Community Hospital — Rochester, New York, United States
University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House — Philadelphia, Pennsylvania, United States
Medical University of South Carolina Alzheimer's Research and Clinical Programs — Charleston, South Carolina, United States
Centre for Addiction and Mental Health — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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