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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Placebo; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080314

CN138-096

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: Aripiprazole

A2

Placebo Comparator group

Treatment:

Drug: Placebo