An 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

Novartis

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: Licarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00238485

CLIC477D2302E1

Details and patient eligibility

About

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.

Enrollment: 251 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent provided prior to participation in the extension study.
• successful completion of the study CLIC477D2302
• willingness and ability to comply with all study requirements

Exclusion criteria

• premature discontinuation from the study CLIC477D2302
• failure to comply with the study CLIC477D2302 protocol

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)