Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Phase 4
Completed
- Conditions
- Bipolar Disorder
- Interventions
- Drug: depakine chrono
- Registration Number
- NCT00477373
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- In or out patients
- Patients with a current diagnosis of Bipolar I Disorder according to DSM IV (296)
- Patients suffering from a current manic episode or mixed episode
Exclusion Criteria
- Patients who participated in a clinical trial within the three preceding months
- Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects.
- Patients with a CNS neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder
- Patients with a history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG with frank paroxysmal activity or a known CT scan of the brain demonstrating gross structural abnormalities
- Patients with uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease
- Patients with acute or chronic hepatitis
- Patients with current or past pancreatitis
- Patients with recent history (3 months or less) of substance or alcohol dependence according to DSM IV
- Pregnancy or lactation. Women of child bearing age should be using a reliable contraceptive method
- Patients that require more than 325 mg of aspirin per day
- Patients with a medical condition which requires the continuous use of medication which could interfere with the evaluation of safety or efficacy of valproate : anticonvulsant or anticoagulant therapy, MAO inhibitors, zidovudine
- Patients having received any depot neuroleptic within six weeks prior to baseline
- Patients who received antidepressant drugs within 5 days before baseline and patients who received fluoxetine within 20 days
- Patients judged by the investigator to have serious risk of suicide
- Patients necessitating an Electro Convulsive Therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 depakine chrono 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.
- Primary Outcome Measures
Name Time Method The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP. D0, D21 and D-end
- Secondary Outcome Measures
Name Time Method Percentage of responders defined by a decrease of at least 50% of the CGI-BP. D0 and D21 Time to achieve 50% and 30% improvement in the CGI-BP score. From randomization to the end of the study Time to a sustained improvement in the CGI-BP. From randomization to the end of the study Time to antidepressants use. From randomization to the end of the study Time to drop-out for any reason. From randomization to the end of the study Safety :Occurrence of any side effect leading to treatment discontinuation. From inform consent signed until patient's recovery or stabilization
Trial Locations
- Locations (2)
Sanofi-aventis administrative office
🇶🇦Qatar, Qatar
Sanofi-Aventis Administrative Office
🇴🇲Muscat, Oman