A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
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|ClinicalTrials.gov Identifier: NCT00249158|
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : November 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease Vascular Dementia||Drug: Risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||344 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Risperidone in the Treatment of Behavioural and Psychological Signs and Symptoms in Dementia (BPSSD): a Multicentre, Double-blind, Placebo-controlled Parallel-group Trial|
|Study Start Date :||March 1998|
|Actual Study Completion Date :||February 2001|
- Change from baseline to the end of double-blind treatment in total aggression score of the CMAI (Cohen-Mansfield Agitation Inventory).
- Change from baseline to end of double-blind treatment in global and total BEHAVE-AD score, BEHAVE-AD cluster scores and in CMAI cluster scores, CGI, and in FAST MMSE; safety evaluations conducted throughout the study.
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): NCT00249158
|Study Director:||Janssen-Cilag Pty Ltd Clinical Trial||Janssen-Cilag Pty Ltd|