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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00477373 |
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.
Condition | Intervention | Phase |
Bipolar Disorder |
Drug: depakine chrono |
Phase IV |
MedlinePlus related topics: | Bipolar Disorder |
ChemIDplus related topics: | Divalproex sodium Valproate Sodium Valproic acid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study |
Estimated Enrollment: | 100 |
Study Start Date: | December 2006 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
If the daily dose does not exceed 1000 mg, Depakine CHRONO can be administered once a day. If the dose is greater than 1000 mg/day, Depakine CHRONO will be administered in a bid regimen: one tablet in the morning and one tablet in the evening.
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Drug: depakine chrono
Depakine Chrono 500 mg
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Bahrain | |||||
Sanofi-aventis administrative office | |||||
Bahrain, Bahrain | |||||
Kuwait | |||||
Sanofi-aventis administrative office | |||||
Kuwait, Kuwait | |||||
Oman | |||||
Sanofi-Aventis Administrative Office | |||||
Muscat, Oman | |||||
Qatar | |||||
Sanofi-aventis administrative office | |||||
Qatar, Qatar |
Sanofi-Aventis |
Study Director: | Hisham - MAHMOUD, MD | Sanofi-aventis administrative office Gulf |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | DPKOT_L_01567 |
First Received: | May 22, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00477373 |
Health Authority: | Kuwait: Ministry of Health |
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