Citalopram for Agitation in Alzheimer's Disease
- Registration Number
- NCT00898807
- Lead Sponsor
- JHSPH Center for Clinical Trials
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo and psychosocial intervention placebo Matching placebo, oral, and psychosocial intervention Citalopram and psychosocial intervention citalopram Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (8)
Monroe Community Hospital
🇺🇸Rochester, New York, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
University of Southern California Keck School of Medicine Memory and Aging Center
🇺🇸Los Angeles, California, United States
Columbia University
🇺🇸New York, New York, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, 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
University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House
🇺🇸Philadelphia, Pennsylvania, United States