Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
NCT00477373 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2008-12-19
Summary
To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode according to DSM IV (APA 1994) over a 12 weeks period of treatment.
To evaluate the clinical safety of Di-valproate.
Conditions
Interventions
- DRUG
-
depakine chrono
Depakine Chrono 500 mg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Hisham - MAHMOUD, MD · Sanofi-aventis administrative office Gulf
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2007-12-31
Countries
- Bahrain
- Kuwait
- Oman
- Qatar
Study Locations
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