A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Phase 3CompletedNCT00094432

Otsuka Pharmaceutical Development & Commercialization, Inc.650 enrolled

Overview

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

650

Conditions

Bipolar I Disorder

Interventions

AripiprazoleDRUG

Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.

PlaceboDRUG

Tablets, Oral, 0 mg, Once daily, 8 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women, ages 18-65 * Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Locations (40)

Outcomes

Primary Outcomes

Mean change from baseline to endpoint on the MADRS total score.

Secondary Outcomes

Clinical Global Impression - Bipolar Version

Severity of illness score depression

Mean change from baseline to endpoint

Data from ClinicalTrials.gov

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Local Institution

Mesa, Arizona, United States

Local Institution

La Mesa, California, United States

Local Institution

La Palma, California, United States

Local Institution

Long Beach, California, United States

Local Institution

Redlands, California, United States

Local Institution

San Diego, California, United States

Local Institution

Sherman Oaks, California, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Coral Springs, Florida, United States

Local Institution

Jacksonville, Florida, United States

...and 30 more locations