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Citalopram for Agitation in Alzheimer's Disease

NCT ID: NCT00898807

Last Updated: 2014-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Alzheimer's Disease Agitation

Keywords

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neuropsychiatric symptoms aggression mood lability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Citalopram and psychosocial intervention

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

Group Type EXPERIMENTAL

citalopram

Intervention Type DRUG

target dose 30mg daily for 9 weeks

Placebo and psychosocial intervention

Matching placebo, oral, and psychosocial intervention

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

daily for 9 weeks

Interventions

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citalopram

target dose 30mg daily for 9 weeks

Intervention Type DRUG

placebo

daily for 9 weeks

Intervention Type DRUG

Other Intervention Names

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Celexa

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

JHSPH Center for Clinical Trials

OTHER

Sponsor Role lead

Responsible Party

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Dave Shade

Director of CitAD Coordinating Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Constantine Lyketsos, MD, MHS

Role: STUDY_CHAIR

Johns Hopkins University

Lon Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California Keck School of Medicine Memory and Aging Center

Bruce Pollock, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Jacobo Mintzer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina Alzheimer's Research and Clinical Programs

David Shade, Esq

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Davengere Devanand, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Paul Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Daniel Weintraub, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Anton Porsteinsson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Jerome Yesavage, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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University of Southern California Keck School of Medicine Memory and Aging Center

Los Angeles, California, United States

Site Status

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Monroe Community Hospital

Rochester, New York, United States

Site Status

University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina Alzheimer's Research and Clinical Programs

Charleston, South Carolina, United States

Site Status

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 22301195 (View on PubMed)

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.

Reference Type RESULT
PMID: 24549548 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24914549 (View on PubMed)

Other Identifiers

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R01AG031348

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0155

Identifier Type: -

Identifier Source: org_study_id