drugset / Trial / NCT00264173

VALID : VAlproate Versus LIthium in Bipolar Disorders

NCT00264173

Phase 4 Completed 270 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective : * To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) \[Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)\] and over a periode of 3 weeks and 12 weeks of treatment Secondary Objective : * To evaluate the clinical and biological safety of valproate compared to lithium.

Timeline

Start
2004-02
Primary completion
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproate Small molecule

Indications