Citalopram for Agitation in Alzheimer's Disease (CitAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dave Shade, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00898807
First received: May 11, 2009
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Agitation
Drug: citalopram
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by JHSPH Center for Clinical Trials:

Primary Outcome Measures:
  • NeuroBehavior Rating Scale [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
  • Modified AD Cooperative Study - Clinical Global Impression of Change (CGIC) [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    Modified AD Cooperative Study - Clinical Global Impression of Change (CGIC) developed to access clinically significant change in agitation


Secondary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    Rating scale for assessing the frequency with which people show certain behaviors.

  • Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898807

Locations
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
Investigators
Study Chair: Constantine Lyketsos, MD, MHS Johns Hopkins University
Study Director: Lon Schneider, MD University of Southern California Keck School of Medicine Memory and Aging Center
Study Director: Bruce Pollock, MD Centre for Addiction and Mental Health
Study Director: Jacobo Mintzer, MD Medical University of South Carolina Alzheimer's Research and Clinical Programs
Study Director: David Shade, Esq Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dave Shade, Director of CitAD Coordinating Center, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00898807     History of Changes
Other Study ID Numbers: IA0155, R01AG031348
Study First Received: May 11, 2009
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by JHSPH Center for Clinical Trials:
neuropsychiatric symptoms
aggression
mood lability

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents

ClinicalTrials.gov processed this record on April 16, 2014