SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients

Summary

The primary objective is: * To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association \[APA\] 2000) and treated for a 3-month period. The secondary objectives are: * To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol; * To assess the patient status 3 weeks and 3 months after inclusion; and * To assess patient satisfaction at 3 months.

Timeline

Start

2004-05

Primary completion

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Completion

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Drugs

Indications