Adolescent Schizophrenia Clinical Trial
Official title:
A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
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
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment