The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
186
target dose 30mg daily for 9 weeks
daily for 9 weeks
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
NeuroBehavior Rating Scale-- Agitation
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.
Time frame: 9 weeks
Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)
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.
Time frame: Baseline to 9 weeks
Cohen-Mansfield Agitation Inventory (CMAI)
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.
Time frame: 9 weeks
Neuropsychiatric Inventory (NPI)-- Agitation Subscore
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.
Time frame: 9 weeks
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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