Study of Aripiprazole in Patients With Acute Bipolar Mania

Otsuka

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Haloperidol; Drug: Aripiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097266

CN138-162

Details and patient eligibility

About

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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615 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

B

Experimental group

Treatment:

Drug: Aripiprazole

C

Active Comparator group

Treatment:

Drug: Haloperidol