Aripiprazole in Children and Adolescents With Bipolar I Disorder

Otsuka

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Aripiprazole; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110461

31-03-240

Details and patient eligibility

About

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Enrollment: 296 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

Exclusion criteria

• Patients with certain other psychological disorders
• Patients with a co-morbid serious, uncontrolled systemic illness
• Patients with significant risk of committing suicide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

296 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Aripiprazole 10 mg tablet

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole

2

Active Comparator group

Description:

Aripiprazole 30 mg tablet

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo