Merck Bipolar 1 P06384
A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder
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| Identifier | P06384 Site Number 3019 |
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| UID | 7d844874-0b76-42cf-b1e5-a26e4f6a0e4c |
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| Status | Done - Archived |
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| Phase | 3b |
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| Category | Bipolar Disorder / Adult |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2012-01-23 10:52 |
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| Last Updated | 2012-01-23 10:52 |
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Description
Key Elements:
• Asenapine (Saphris®, Sycrest®) is a new atypical antipsychotic developed for the treatment of schizophrenia and acute mania associated with bipolar disorder.
• The purpose of this study is to determine whether asenapine is safe and effective in preventing mood episodes compared to placebo.
• Study drug administration: 1 tablet (administered sublingually) twice-daily
• Subjects will be randomized to one of the two treatment groups (asenapine or placebo) in a 1:1 ratio. There is a 50% chance of placebo.
• Duration: 19 Office Visits (Approximately 43-47 weeks)
• $45 per office visit
• Subjects must be willing to be washed off of their current antipsychotic medication
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