Study of Aripiprazole in Patients With Bipolar I Disorder

Otsuka

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00257972

CN138-134

Details and patient eligibility

About

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion criteria

First manic or mixed episode
Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole