A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Otsuka

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Lithium or Valproate with placebo (PBO); Drug: Lithium or Valproate with Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261443

CN138-189

Details and patient eligibility

About

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Enrollment: 1,270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Men and women > or = to 18 years of age meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,270 participants in 2 patient groups, including a placebo group

A1

Placebo Comparator group

Description:

/Active Comparator

Treatment:

Drug: Lithium or Valproate with placebo (PBO)

A2

Experimental group

Treatment:

Drug: Lithium or Valproate with Aripiprazole