Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study (GEVANS)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00477373
First received: May 22, 2007
Last updated: December 18, 2008
Last verified: December 2008
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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
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 May 16, 2013