Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

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.