Oral Aripiprazole Open-Label Rollover Study

Otsuka

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001702

31-05-243

Details and patient eligibility

About

The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.

Enrollment: 85 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

Exclusion criteria

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

Trial design

85 participants in 1 patient group

Oral Aripiprazole

Experimental group

Description:

Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.

Treatment:

Drug: Aripiprazole