Study of Aripiprazole in Patients With Bipolar I Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Bipolar Disorder

Interventions

aripiprazoleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (90)

Outcomes

Primary Outcomes

Change from baseline to endpoint in a mania rating scale

Secondary Outcomes

Response rate and Clinical Global Impression Scale at endpoint

Data from ClinicalTrials.gov

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Local Institution

Little Rock, Arkansas, United States

Local Institution

Riverside, California, United States

Local Institution

Deerfield Beach, Florida, United States

Local Institution

Jacksonville, Florida, United States

Local Institution

Maitland, Florida, United States

Local Institution

Hoffman Estates, Illinois, United States

Local Institution

Oak Brook, Illinois, United States

Local Institution

Newton, Kansas, United States

Local Institution

Newton, Massachusetts, United States

Local Institution

New York, New York, United States

...and 80 more locations