A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multicenter Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in the Treatment of Subjects With Acute Manic and Mixed Episodes Associated With Bipolar I Disorder
Sponsor study identifier
interventional
473
0 countries
N/A
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2007
Actual (reported)Study Completion
June 2007
Actual (reported)The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone extended release on global functioning, and the relationship between blood levels and the effectiveness and safety of paliperidone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 3, 2006
Actual (reported)March 7, 2006
Actual (reported)June 2007
Actual (reported)June 2007
Actual (reported)The primary effectiveness outcome is the change in the total Young Mania Rating Scale score from baseline to the last assessment during the 3 week double-blind treatment phase.
The secondary effectiveness outcome is the change in Global Assessment of Functional Scale from baseline to endpoint or the last assessment during the double-blind treatment phase.
Berwaerts J, Xu H, Nuamah I, Lim P, Hough D. Evaluation of the efficacy and safety of paliperidone extended-release in the treatment of acute mania: a randomized, double-blind, dose-response study. J Affect Disord. 2012 Jan;136(1-2):e51-e60. doi: 10.1016/j.jad.2010.06.030. Epub 2010 Jul 10.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
473 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2006
First Posted
March 7, 2006
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2007
Actual (reported)Study Completion
June 2007
Actual (reported)Last Updated
June 9, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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