The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
Phase 4
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00154323
- Lead Sponsor
- Novartis
- Brief Summary
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- History of bipolar disorder type I or II
Exclusion Criteria
- Other serious medical conditions
- Treatment with antiepileptic medications
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Duration of remission
- Secondary Outcome Measures
Name Time Method Time to new maniac/hypomanic episode Time to new depressive episode Change from baseline in functional activity Daily mood fluctuation Number of relapsed patients at study completion and type/severity of episode