A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acu...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-000846-38

A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder

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Extrait

The primary objectives of this study are to evaluate the efficacy of extended-release paliperidone (paliperidone ER) compared with placebo in the prevention of the recurrence of any mood symptoms (i.e., manic or depressive) associated with Bipolar I Disorder and to assess the safety and tolerability of paliperidone ER in subjects who maintain clinical stability after an acute manic or mixed episode.


Critère d'inclusion

  • Bipolar I disorder, most recent maniac or mixed episode

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