A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2000 mg/d in the treatment of manic episodes of bipolar I disorder - D2303E1

Phase 1

• Conditions: Bipolar I disorder, manic and mixed episodes; MedDRA version: 8.1Level: LLTClassification code 10004939Term: Bipolar I disorder

• Registration Number: EUCTR2004-000687-27-SK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-26
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. written informed consent provided prior to participation in the extension study
2. successful completion of study CLIC477D2303
3. cooperation and willingness to comply with all study requirements
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

1. premature discontinuation from study CLIC477D2303
2. failure to comply with study CLIC477D2303

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified