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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: depakine chrono

Study type: Interventional

Funder types: Industry

Identifiers

NCT00477373

DPKOT_L_01567

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

1

Experimental group

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.

Treatment:

Drug: depakine chrono