Conditions: Adolescent Schizophrenia Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Keywords: schizophrenia adolescent bipolar
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 524
Healthy volunteers: no

Brief summary:
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.

The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.

Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study

Detailed description:

Arms:
arm 1: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Protocol document: