Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Phase 3
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00107939
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 453
Inclusion Criteria
- Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
- In need of psychiatric treatment
- Cooperation and willingness to complete all aspects of the study
Exclusion Criteria
- Current diagnosis other than bipolar I disorder
- History of schizophrenia or schizoaffective disorder
- Drug dependence within 1 month prior to study start or testing positive in a urine drug test
- Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
- Any form of psychotherapy within 1 month prior to study start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
- Secondary Outcome Measures
Name Time Method Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.
Trial Locations
- Locations (2)
Investigational Site
🇺🇸West Allis, Wisconsin, United States
Invetigational Site
🇺🇸Brooklyne, New York, United States