VALID : VAlproate Versus LIthium in Bipolar Disorders

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00264173
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Study Completion: 2006-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-15
• Last Update Posted: 2007-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to D END in the Young Mania Rating Scale total score

Secondary Outcome Measures

Name	Time	Method
Change from baseline to each assessment in the YMRS score
Percentage of responders defined by a decrease of at least 50% in the YMRS score between D0 and D END
Percentage of responders at week 3 defined by a decrease of at least 50 % in the YMRS score between D0 and D21
Change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) (20) between D0 and D21
Change in the CGI-BP between D0 and D END
Change in the MADRS between D0 and D21 (MADRS: Montgomery and Asberg Depression Rating Scale )
Change in the MADRS between D0 and D END
Survival analyses: Time to achieve 50% and 30% improvement in the YMRS score; Time to antidepressant intake; Time to drop-out for any reason.