Bipolar Disorder
Conditions
Brief 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.
Interventions
DRUGdepakine chrono
Depakine Chrono 500 mg
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve 50% and 30% improvement in the CGI-BP score. | From randomization to the end of the study |
| Time to a sustained improvement in the CGI-BP. | From randomization to the end of the study |
| Percentage of responders defined by a decrease of at least 50% of the CGI-BP. | D0 and D-end |
| Time to drop-out for any reason. | From randomization to the end of the study |
| Safety :Occurrence of any side effect leading to treatment discontinuation. | From inform consent signed until patient's recovery or stabilization |
| Time to antidepressants use. | From randomization to the end of the study |
Countries
Bahrain, Kuwait, Oman, Qatar
Outcome results
None listed