A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

Novartis Pharmaceuticals1 site in 1 country320 target enrollmentNovember 2004

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bipolar Disorder
Sponsor: Novartis Pharmaceuticals
Enrollment: 320
Locations: 1
Primary Endpoint: Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
Status: Completed
Last Updated: 9 years ago

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

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

August 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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