A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Licarbazepine 750 ¿ 2000 mg/d as Adjunctive Therapy to an Atypical Antipsychotic in the Treatment of Manic Episodes of Bipolar I Disorder Over 6 Weeks

Novartis Pharmaceuticals2 sites in 1 country453 target enrollmentNovember 2004

ConditionsBipolar Disorder

DrugsLicarbazepine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bipolar Disorder
Sponsor: Novartis Pharmaceuticals
Enrollment: 453
Locations: 2
Primary Endpoint: Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

April 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)

Secondary Outcomes

Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.