NCT00898807|CompletedPhase 3ResultsDMC
Citalopram for Agitation in Alzheimer's Disease
CitAD
A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
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Sponsor study identifier
Secondary identifiers
NIH
interventional
186
2 countries
8
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 11, 2009
Actual (reported)May 12, 2009
Actual (reported)July 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2013
Actual (reported)September 2013
Actual (reported)June 27, 2014
Actual (reported)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.
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.
Baseline to 9 weeks
Cohen-Mansfield Agitation Inventory (CMAI)
9 weeks
Neuropsychiatric Inventory (NPI)-- Agitation Subscore
9 weeks
Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
Matching placebo, oral, and psychosocial intervention
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, 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
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
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.
Porsteinsson AP, Drye LT, Pollock BG, Devanand DP, Frangakis C, Ismail Z, Marano C, Meinert CL, Mintzer JE, Munro CA, Pelton G, Rabins PV, Rosenberg PB, Schneider LS, Shade DM, Weintraub D, Yesavage J, Lyketsos CG; CitAD Research Group. Effect of citalopram on agitation in Alzheimer disease: the CitAD randomized clinical trial. JAMA. 2014 Feb 19;311(7):682-91. doi: 10.1001/jama.2014.93.
Constantine Lyketsos, MD, MHS
Johns Hopkins University
Lon Schneider, MD
University of Southern California Keck School of Medicine Memory and Aging Center
Bruce Pollock, MD
Centre for Addiction and Mental Health
Jacobo Mintzer, MD
Medical University of South Carolina Alzheimer's Research and Clinical Programs
186 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2009
First Posted
May 12, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Serotonergic Pharmacotherapy for Agitation of Dementia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Charleston, South Carolina, 29406, United States
Centre for Addiction and Mental Health
Toronto, Ontario, M6J1H4, Canada
Drye LT, Spragg D, Devanand DP, Frangakis C, Marano C, Meinert CL, Mintzer JE, Munro CA, Pelton G, Pollock BG, Porsteinsson AP, Rabins PV, Rosenberg PB, Schneider LS, Shade DM, Weintraub D, Yesavage J, Lyketsos CG; CitAD Research Group. Changes in QTc interval in the citalopram for agitation in Alzheimer's disease (CitAD) randomized trial. PLoS One. 2014 Jun 10;9(6):e98426. doi: 10.1371/journal.pone.0098426. eCollection 2014.
David Shade, Esq
Johns Hopkins University
Davengere Devanand, MD
Columbia University
Paul Rosenberg, MD
Johns Hopkins University
Daniel Weintraub, MD
University of Pennsylvania
Anton Porsteinsson, MD
University of Rochester
Jerome Yesavage, MD
Stanford University
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
June 27, 2014
Results First Posted
June 27, 2014
Record last verified: 2014-06
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Source: ClinicalTrials.gov.
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