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

Otsuka

Status and phase: Withdrawn; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Placebo; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00338273

CN138-149

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients
• Must sign informed consent prior to protocol-related procedures

Exclusion criteria

• Women who are pregnant, trying to become pregnant, or nursing
• Significant risk of committing suicide
• Any serious unstable medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: Aripiprazole

A2

Placebo Comparator group

Treatment:

Drug: Placebo