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A Phase 3, randomized, 6-month, double blind trial in subjects with Bipolar I Disorder to evaluate the continued safety and maintenance of effect of Ziprasidone plus a mood stabilizer (vs placebo plus...

Update Il y a 4 ans
Reference: EUCTR2005-004167-27

A Phase 3, randomized, 6-month, double blind trial in subjects with Bipolar I Disorder to evaluate the continued safety and maintenance of effect of Ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 2 months of response to open-label treatment with both agents

Woman and Man

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Extract

To achieve a long-term maintenance indication for bipolar disorder by comparing the time to intervention for a mood episode (TIME) in subjects receiving double-blind ziprasidone plus a mood stabilizer vs. subjects receiving placebo plus a mood stabilizer.

Inclusion criteria

  • Bipolar I Disorder

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