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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00477373
First received: May 22, 2007
Last updated: December 18, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: depakine chrono
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of responders defined by a decrease of at least 50% of the CGI-BP. [ Time Frame: D0 and D-end ] [ Designated as safety issue: No ]
  • Percentage of responders defined by a decrease of at least 50% of the CGI-BP. [ Time Frame: D0 and D21 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Time to a sustained improvement in the CGI-BP. [ Time Frame: From randomization to the end of the study ] [ Designated as safety issue: No ]
  • Time to antidepressants use. [ Time Frame: From randomization to the end of the study ] [ Designated as safety issue: No ]
  • Time to drop-out for any reason. [ Time Frame: From randomization to the end of the study ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: December 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477373

Locations
Bahrain
Sanofi-aventis administrative office
Bahrain, Bahrain
Kuwait
Sanofi-aventis administrative office
Kuwait, Kuwait
Oman
Sanofi-Aventis Administrative Office
Muscat, Oman
Qatar
Sanofi-aventis administrative office
Qatar, Qatar
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Hisham - MAHMOUD, MD Sanofi-aventis administrative office Gulf
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00477373     History of Changes
Other Study ID Numbers: DPKOT_L_01567
Study First Received: May 22, 2007
Last Updated: December 18, 2008
Health Authority: Kuwait: Ministry of Health

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on July 26, 2014