Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Novartis

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: licarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139594

CLIC477D2303E1

Details and patient eligibility

About

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

Enrollment: 181 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 study CLIC477D2303
• cooperation and willingness to comply with all study requirements

Exclusion criteria

• premature discontinuation from study CLIC477D2303
• failure to comply with study CLIC477D2303

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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181 participants in 1 patient group

licarbazepine

Experimental group

Treatment:

Drug: licarbazepine