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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stab...

Update Il y a 4 ans
Reference: EUCTR2005-005345-19

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

Woman and Man

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Extract

The primary objective of this trial is to assess the adjunctive anti-manic efficacy of paliperidone ER relative to placebo during 6 weeks of treatment in subjects with Bipolar I Disorder who are suffering from a manic episode and who already have been taking lithium or valproate for treatment of Bipolar I Disorder. The primary efficacy measure is the change from baseline to endpoint in the Young Mania Rating Scale (YMRS) total score at study end.

Inclusion criteria

  • Bipolar I Disorder

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