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

Novartis Pharmaceuticals453 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

453

Conditions

Bipolar Disorder

Interventions

LicarbazepineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (22)

Investigational Site

Little Rock, Arkansas, United States

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.

Data from ClinicalTrials.gov

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