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A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the tr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001490-15

A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the treatment of subjects with bipolar I disorder

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Extrait

To evaluate the efficacy of risperidone long-acting injectable (LAI) versus placebo in the prevention of a mood episode (recurrence event) in subjects with bipolar I disorder after a 12-week (3-month) stabilazion period on risperidone LAI, as measured by the time to recurrence of any mood episode.

Critère d'inclusion

  • Subjects with a diagnosos of bipolar I disorder who are currently experiencing a manic or mixed episode (YMRS>20 and CGI-S>/= 4 [moderate]) or who are between mood episodes (non-acute; YMRS<12 and CGI-S</=3 [mild]), who do meet DSM-IV-TR criteria for a depressive episode

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