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

Novartis

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Licarbazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00107939

CLIC477D2302

Details and patient eligibility

About

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.

Enrollment

453 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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