Citalopram for Agitation in Alzheimer's Disease (CitAD)
This study is ongoing, but not recruiting participants.
Sponsor:
JHSPH Center for Clinical Trials
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
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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
- the frequency of agitation as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or
- 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:
| 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 May 21, 2013