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Trial record 74 of 588 for:    ESCITALOPRAM AND Celexa

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

Tracking Information
First Submitted Date  ICMJE May 11, 2009
First Posted Date  ICMJE May 12, 2009
Results First Submitted Date  ICMJE March 19, 2014
Results First Posted Date  ICMJE June 27, 2014
Last Update Posted Date June 27, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
NeuroBehavior Rating Scale [ Time Frame: every 3 weeks over 9 weeks ]
Change History Complete list of historical versions of study NCT00898807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
  • Alzheimer's Disease Cooperative Study-Clinical Global Impression Of Change (ADCS-CGIC), modified [ Time Frame: every 3 weeks over 9 weeks ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: every 3 weeks over 9 weeks ]
  • Udvalg for Kliniske Undersogelser (UKU) side effects rating scale [ Time Frame: every 3 weeks over 9 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Citalopram for Agitation in Alzheimer's Disease
Official Title  ICMJE A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
Brief Summary The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Agitation
Intervention  ICMJE
  • Drug: citalopram
    target dose 30mg daily for 9 weeks
    Other Name: Celexa
  • Drug: placebo
    daily for 9 weeks
Study Arms  ICMJE
  • Experimental: Citalopram and psychosocial intervention
    Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
    Intervention: Drug: citalopram
  • Placebo Comparator: Placebo and psychosocial intervention
    Matching placebo, oral, and psychosocial intervention
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2014)
186
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2009)
200
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00898807
Other Study ID Numbers  ICMJE IA0155
R01AG031348 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dave Shade, Johns Hopkins University
Study Sponsor  ICMJE JHSPH Center for Clinical Trials
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
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
PRS Account JHSPH Center for Clinical Trials
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP