Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study (GEVANS)

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: depakine chrono

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bahrain
  • Bahrain, Bahrain
    • Sanofi-Aventis Administrative Office
• Kuwait
  • Kuwait, Kuwait
    • Sanofi-Aventis Administrative Office
• Oman
  • Muscat, Oman
    • Sanofi-Aventis Administrative Office
• Qatar
  • Qatar, Qatar
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: depakine chrono; Depakine Chrono 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Hisham - MAHMOUD, MD, Sanofi-aventis administrative office Gulf

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: May 22, 2007
• First Submitted That Met QC Criteria: May 22, 2007
• First Posted (Estimate): May 23, 2007

Study Record Updates

• Last Update Posted (Estimate): December 19, 2008
• Last Update Submitted That Met QC Criteria: December 18, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: DPKOT_L_01567