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
Summary
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-- AgitationModified 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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