Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

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

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.

Intervention(s) in this Clinical Trial

• Drug: depakine chrono
  • Depakine Chrono 500 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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 Measures

• The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP.
  • Time Frame: D0, D21 and D-end
    Safety Issue?: No

Secondary Measures

• Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
  • Time Frame: D0 and D-end
    Safety Issue?: No
• Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
  • Time Frame: D0 and D21
    Safety Issue?: No
• Time to achieve 50% and 30% improvement in the CGI-BP score.
  • Time Frame: From randomization to the end of the study
    Safety Issue?: No
• Time to a sustained improvement in the CGI-BP.
  • Time Frame: From randomization to the end of the study
    Safety Issue?: No
• Time to antidepressants use.
  • Time Frame: From randomization to the end of the study
    Safety Issue?: No
• Time to drop-out for any reason.
  • Time Frame: From randomization to the end of the study
    Safety Issue?: No
• Safety :Occurrence of any side effect leading to treatment discontinuation.
  • Time Frame: From inform consent signed until patient's recovery or stabilization
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Hisham - MAHMOUD, MD Study Director Sanofi-aventis administrative office Gulf  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00477373

Study ID Number: DPKOT_L_01567

ClinicalTrials.gov Identifier: NCT00477373

Health Authority: Kuwait: Ministry of Health