Treating Behavioral Disturbances in Individuals With Dementia
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|ClinicalTrials.gov Identifier: NCT00073658|
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : March 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Drug: Citalopram Drug: Risperidone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
|United States, Pennsylvania|
|University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Bruce G. Pollock, MD, PhD||University of Pittsburgh|