Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00099229
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted QC: 2004-12-09
• Study First Submitted: 2004-12-10
• Study First Posted: 2004-12-10
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 3).

Secondary Outcome Measures

Name	Time	Method
Major improvement in anxiety and depression from baseline to endpoint (Week 3)

Trial Locations

Locations (1)

Investigational Site; 🇷🇺 St. Petersburg, Russian Federation