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A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared with Flexibly...

Update Il y a 4 ans
Reference: EUCTR2005-005812-25

A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared with Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes Associated with Bipolar I Disorder

Woman and Man

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Extract

The primary objectives of the study are to demonstrate the antimanic efficacy and to assess the safety of flexibly dosed paliperidone extended release (ER) compared with placebo during 3 weeks of treatment in subjects with Bipolar I Disorder who are experiencing an acute manic or mixed episode

Inclusion criteria

  • Bipolar I Disorder

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