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Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study (GEVANS)
To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode according to DSM IV (APA 1994) over a 12 weeks period of treatment. To evaluate the clinical safety of Di-valproate.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 70 |
| Start date | 2006-12 |
Conditions
- Bipolar Disorder
Interventions
- depakine chrono
Primary outcomes
- The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP. — D0, D21 and D-end
Countries
Bahrain, Kuwait, Oman, Qatar