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Treating Behavioral Disturbances in Individuals With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073658
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : March 10, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).

Condition or disease Intervention/treatment Phase
Dementia Drug: Citalopram Drug: Risperidone Phase 2

Detailed Description:

Dementia-related behavioral disturbances have been associated with excess disability, increased caregiver burden, and premature institutionalization. Pharmacotherapy is often necessary to treat these disturbances. This study will use citalopram and risperidone to treat people with dementia-related behavior problems.

Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start. Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks. Limited doses of the sedative lorazepam may be administered as needed throughout the study. During the first 2 weeks of the study, participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized. Following hospital discharge, participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks. Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter. Experimental laboratory measures will be collected at study start, Week 1, Week 2, and every 2 weeks thereafter until Week 12. Upon study completion, patients may continue to receive citalopram or risperidone under the supervision of their current physicians. Three months after study completion, participants may be contacted for a follow-up report of their psychiatric and medical status.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Continuation Pharmacotherapy for Agitation of Dementia
Study Start Date : January 2000
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia





Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's type dementia and/or meet criteria for probable or possible Alzheimer's disease
  • Inpatient admittance to Western Psychiatric Institute and Clinic
  • Written informed consent from participant's legally authorized representative with the participant's assent
  • Psychosis or behavioral problems severe enough to be a danger to the participant's health, well-being, or safety
  • Score of 3 to 6 (moderate to severe) on at least one of the Neurobehavioral Rating Scale (NBRS) agitation or psychosis items
  • Ability to participate in study evaluation and ingest oral medication

Exclusion Criteria:

  • Diagnosis of an unstable medical illness within the last 12 months
  • Kidney or liver dysfunction
  • Diagnosis of delirium, substance-induced persisting dementia, or vascular dementia
  • Score of 12 or higher on the Cornell Scale for Depression in Dementia, and a score greater than 3 on the depression item of the NBRS
  • Diagnosis of Parkinson's disease or any neurological illness which may affect cognitive function
  • History of schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, or bipolar affective disorder
  • Alcohol or substance abuse or dependence
  • Receiving monoamine oxidase inhibitors within 15 days of study
  • Display behaviors which could endanger the participant's life or the lives of others
  • Received fluoxetine within 4 weeks of screening

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): NCT00073658


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Bruce G. Pollock, MD, PhD University of Pittsburgh

Publications:
Mamo DC, Sweet RA, Mulsant BH, Rosen J, Pollock BG: Neuroleptic-induced Parkinsonism in Alzheimer's disease. Psychiatric Annals 32:249-252, 2002.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00073658     History of Changes
Other Study ID Numbers: R01MH059666-02 ( U.S. NIH Grant/Contract )
R01MH059666-02 ( U.S. NIH Grant/Contract )
DSIR GT-GP
First Posted: December 3, 2003    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014

Keywords provided by University of Pittsburgh:
Alzheimer disease
Aggression
Delusions
Paranoid behavior

Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Risperidone
Citalopram
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents