A 52 week open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2500 mg/d in the treatment of manic episodes of bipolar I disorder
Active, not recruiting
- Conditions
- Bipolar I disorder, manic and mixed episodesDSM-IV criteria 296.0, 296.4 or 296.6
- Registration Number
- EUCTR2004-000687-27-AT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 215
Inclusion Criteria
•successful completion of study CLIC477D2303
•written informed consent provided prior to participation in the extension study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•premature discontinuation from study CLIC477D2303
•failure to comply with the study CLIC477D2303 protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method