Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Bipolar Disorder Clinical Trial

— GEVANS  

Official title:

Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477373
• Other study ID #: DPKOT_L_01567
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2007
• Last updated: December 18, 2008
• Start date: December 2006

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kuwait: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• depakine chrono
Depakine Chrono 500 mg

Locations

Country	Name	City	State
Bahrain	Sanofi-aventis administrative office	Bahrain
Kuwait	Sanofi-aventis administrative office	Kuwait
Oman	Sanofi-Aventis Administrative Office	Muscat
Qatar	Sanofi-aventis administrative office	Qatar

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bahrain,  Kuwait,  Oman,  Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of responders defined by a decrease of at least 50% of the CGI-BP.		D0 and D-end	No
Secondary	Percentage of responders defined by a decrease of at least 50% of the CGI-BP.		D0 and D21	No
Secondary	Time to achieve 50% and 30% improvement in the CGI-BP score.		From randomization to the end of the study	No
Secondary	Time to a sustained improvement in the CGI-BP.		From randomization to the end of the study	No
Secondary	Time to antidepressants use.		From randomization to the end of the study	No
Secondary	Time to drop-out for any reason.		From randomization to the end of the study	No
Secondary	Safety :Occurrence of any side effect leading to treatment discontinuation.		From inform consent signed until patient's recovery or stabilization	Yes