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

2014-07-24 14:29:18 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bipolar Disorder

Intervention

Amisulpride

Location

Sanofi-Aventis
Prague
Czech Republic

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:29:18-0400

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