Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Study Overview
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Brief Summary
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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.

Official Title
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Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: depakine chrono


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: depakine chrono<br>* Depakine Chrono 500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responders defined by a decrease of at least 50% of the CGI-BP. |  | D0 and D-end | 
| 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 |