The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.

Novartis55 enrolled

Overview

Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder

Interventions

OxcarbazepineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of bipolar disorder type I or II Exclusion Criteria: * Other serious medical conditions * Treatment with antiepileptic medications Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Duration of remission

Secondary Outcomes

Daily mood fluctuation

Time to new maniac/hypomanic episode

Time to new depressive episode

Number of relapsed patients at study completion and type/severity of episode

Change from baseline in functional activity

Data from ClinicalTrials.gov

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