Status:
COMPLETED
Citalopram for Agitation in Alzheimer's Disease
Lead Sponsor:
JHSPH Center for Clinical Trials
Collaborating Sponsors:
National Institute on Aging (NIA)
National Institute of Mental Health (NIMH)
Conditions:
Alzheimer's Disease
Agitation
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
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 pharmacogenomi...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00898807
Start Date
July 1 2009
End Date
September 1 2013
Last Update
June 27 2014
Active Locations (8)
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1
University of Southern California Keck School of Medicine Memory and Aging Center
Los Angeles, California, United States, 90089
2
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
3
Johns Hopkins University
Baltimore, Maryland, United States, 21224
4
Columbia University
New York, New York, United States, 10032