A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.
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|ClinicalTrials.gov Identifier: NCT00250367|
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : November 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Manic Disorder||Drug: risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Safety And Efficacy Of Risperdal� (Risperidone) Versus Placebo As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder|
|Study Start Date :||October 1997|
|Actual Study Completion Date :||November 1999|
- Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment
- Changes from baseline to end of double-blind treatment in Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) - severity, and Hamilton Depression Rating Scale (HAMD); incidence of adverse events throughout 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): NCT00250367
|Study Director:||Janssen Pharmaceutica N.V. Clinical Trial||Janssen Pharmaceutica N.V.|