Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Valproic Acid

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.