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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00073658 |
Purpose
This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).
| Condition | Intervention | Phase |
|
Dementia |
Drug: Citalopram Drug: Risperidone |
Phase II |
| Genetics Home Reference related topics: | Alzheimer disease |
| MedlinePlus related topics: | Dementia |
| Drug Information available for: | Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Risperidone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Continuation Pharmacotherapy for Agitation of Dementia |
| Estimated Enrollment: | 137 |
| Study Start Date: | January 2000 |
| Study Completion Date: | June 2005 |
| Estimated Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | R01 MH59666-02, DSIR GT-GP |
| First Received: | December 2, 2003 |
| Last Updated: | February 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00073658 |
| Health Authority: | United States: Food and Drug Administration |
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