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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
depakine chrono
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-aventis administrative office
  • Sanofi-aventis administrative office
  • Sanofi-Aventis Administrative Office
  • Sanofi-aventis administrative office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Time to achieve 50% and 30% improvement in the CGI-BP score.
Time to a sustained improvement in the CGI-BP.
Time to antidepressants use.
Time to drop-out for any reason.
Safety :Occurrence of any side effect leading to treatment discontinuation.

Full Information

First Posted
May 22, 2007
Last Updated
December 18, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00477373
Brief Title
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Acronym
GEVANS
Official Title
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
depakine chrono
Intervention Description
Depakine Chrono 500 mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Time Frame
D0 and D-end
Title
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Time Frame
D0 and D21
Title
Time to achieve 50% and 30% improvement in the CGI-BP score.
Time Frame
From randomization to the end of the study
Title
Time to a sustained improvement in the CGI-BP.
Time Frame
From randomization to the end of the study
Title
Time to antidepressants use.
Time Frame
From randomization to the end of the study
Title
Time to drop-out for any reason.
Time Frame
From randomization to the end of the study
Title
Safety :Occurrence of any side effect leading to treatment discontinuation.
Time Frame
From inform consent signed until patient's recovery or stabilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham - MAHMOUD, MD
Organizational Affiliation
Sanofi-aventis administrative office Gulf
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis administrative office
City
Bahrain
Country
Bahrain
Facility Name
Sanofi-aventis administrative office
City
Kuwait
Country
Kuwait
Facility Name
Sanofi-Aventis Administrative Office
City
Muscat
Country
Oman
Facility Name
Sanofi-aventis administrative office
City
Qatar
Country
Qatar

12. IPD Sharing Statement

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Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

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