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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: Aripiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094432

CN138-146

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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650 participants in 2 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: Aripiprazole

A2

Placebo Comparator group

Treatment:

Drug: Placebo