A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
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|ClinicalTrials.gov Identifier: NCT00249236|
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Manic Episode||Drug: Risperidone, oral tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||291 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Or Mixed Episodes Associated With Bipolar I Disorder|
|Study Start Date :||March 2001|
|Actual Study Completion Date :||December 2001|
- Change in Young Mania Rating Scale (YMRS) total score from baseline to end of treatment.
- Change from baseline to end of treatment in Clinical Global Impression-Severity of Illness (CGI-S) scale, Global Assessment Scale (GAS), and Positive and Negative Syndrome Scale (PANSS) total score; 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): NCT00249236
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|