VALID : VAlproate Versus LIthium in Bipolar Disorders
NCT00264173 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2007-11-16
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.
Conditions
Interventions
- DRUG
-
Valproate sodium
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Robert MANFREDI, MD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-02-29
- Completion
- 2006-09-30
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