Aripiprazole Open-Label, Safety and Tolerability Study (APEX 241)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Schizophrenia; Bipolar Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102518

31-03-241

Details and patient eligibility

About

The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.

Enrollment: 325 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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325 participants in 1 patient group

NCT00102063 and NCT00110461 Subjects

Experimental group

Description:

All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).

Treatment:

Drug: Aripiprazole