A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder
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|ClinicalTrials.gov Identifier: NCT00257075|
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : January 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorders Manic Episode||Drug: Risperidone, oral tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Episodes Associated With Bipolar I Disorder.|
|Study Start Date :||December 2000|
|Actual Study Completion Date :||May 2002|
- Change in Young Mania Rating Scale (YMRS) total score from baseline to the end of treatment.
- Change from baseline to the 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): NCT00257075
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|