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Citalopram for Agitation in Alzheimer's Disease (CitAD)

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ClinicalTrials.gov Identifier: NCT00898807
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dave Shade, Johns Hopkins University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Agitation Drug: citalopram Drug: placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
Study Start Date : July 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Citalopram and psychosocial intervention
Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
 Drug: citalopram
target dose 30mg daily for 9 weeks
Other Name: Celexa
Placebo Comparator: Placebo and psychosocial intervention
Matching placebo, oral, and psychosocial intervention
 Drug: placebo
daily for 9 weeks


Outcome Measures
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Primary Outcome Measures :
  1. NeuroBehavior Rating Scale-- Agitation [ Time Frame: 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.

  2. Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 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.

  2. Neuropsychiatric Inventory (NPI)-- Agitation Subscore [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898807


Locations
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United States, California
University of Southern California Keck School of Medicine Memory and Aging Center
Los Angeles, California, United States, 90089
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, New York
Columbia University
New York, New York, United States, 10032
Monroe Community Hospital
Rochester, New York, United States, 14559
United States, Pennsylvania
University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina Alzheimer's Research and Clinical Programs
Charleston, South Carolina, United States, 29406
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institute on Aging (NIA)
National Institute of Mental Health (NIMH)
Investigators
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Study Chair: Constantine Lyketsos, MD, MHS Johns Hopkins University
Principal Investigator: Lon Schneider, MD University of Southern California Keck School of Medicine Memory and Aging Center
Principal Investigator: Bruce Pollock, MD Centre for Addiction and Mental Health
Principal Investigator: Jacobo Mintzer, MD Medical University of South Carolina Alzheimer's Research and Clinical Programs
Principal Investigator: David Shade, Esq Johns Hopkins University
Principal Investigator: Davengere Devanand, MD Columbia University
Principal Investigator: Paul Rosenberg, MD Johns Hopkins University
Principal Investigator: Daniel Weintraub, MD University of Pennsylvania
Principal Investigator: Anton Porsteinsson, MD University of Rochester
Principal Investigator: Jerome Yesavage, MD Stanford University
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dave Shade, Director of CitAD Coordinating Center, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00898807    
Other Study ID Numbers: IA0155
R01AG031348 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014
Last Verified: June 2014
Keywords provided by Dave Shade, Johns Hopkins University:
neuropsychiatric symptoms
aggression
mood lability
Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
 Neurobehavioral Manifestations
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs