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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00477373
Recruitment Status : Completed
First Posted : May 23, 2007
Last Update Posted : December 19, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: depakine chrono Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Study Start Date : December 2006
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage of responders defined by a decrease of at least 50% of the CGI-BP. [ Time Frame: D0 and D-end ]
  2. Percentage of responders defined by a decrease of at least 50% of the CGI-BP. [ Time Frame: D0 and D21 ]
  3. Time to achieve 50% and 30% improvement in the CGI-BP score. [ Time Frame: From randomization to the end of the study ]
  4. Time to a sustained improvement in the CGI-BP. [ Time Frame: From randomization to the end of the study ]
  5. Time to antidepressants use. [ Time Frame: From randomization to the end of the study ]
  6. Time to drop-out for any reason. [ Time Frame: From randomization to the end of the study ]
  7. Safety :Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: From inform consent signed until patient's recovery or stabilization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477373

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Sanofi-aventis administrative office
Bahrain, Bahrain
Sanofi-aventis administrative office
Kuwait, Kuwait
Sanofi-Aventis Administrative Office
Muscat, Oman
Sanofi-aventis administrative office
Qatar, Qatar
Sponsors and Collaborators
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Study Director: Hisham - MAHMOUD, MD Sanofi-aventis administrative office Gulf
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00477373    
Other Study ID Numbers: DPKOT_L_01567
First Posted: May 23, 2007    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs