Aripiprazole in Patients With Acute Mania

Otsuka Pharmaceutical Development & Commercialization, Inc.615 enrolled

Overview

The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

615

Conditions

Bipolar Disorder

Interventions

aripiprazoleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary diagnosis of Acute Bipolar I Mania Exclusion Criteria: * Patients with a DSM-IV diagnosis other than Bipolar I Mania

Locations (38)

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

Tuscaloosa, Alabama, United States

Local Institution

Scottsdale, Arizona, United States

Local Institution

Cerritos, California, United States

Local Institution

Garden Grove, California, United States

Local Institution

La Palma, California, United States

Local Institution

Riverside, California, United States

Local Institution

San Diego, California, United States

Local Institution

Denver, Colorado, United States

Local Institution

Middletown, Connecticut, United States

Local Institution

New Haven, Connecticut, United States

...and 28 more locations