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

Otsuka Pharmaceutical Development & Commercialization, Inc.400 enrolled

Overview

The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Bipolar 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

* ages 18-65 * Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Locations (28)

Local Institution

Tuscaloosa, Alabama, United States

Outcomes

Primary Outcomes

Change on a depression rating scale at endpoint

Secondary Outcomes

Response rate and Clinical Global Impression scale at endpoint

Data from ClinicalTrials.gov

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