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A Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia

2014-07-24 14:05:45 | BioPortfolio

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) and rollover subjects from the 31-09-266 double blind study. All de novo subjects must enter the screening period of the study and all rollover subjects must enter Phase 1 of the study. Subjects who are screened and are not required to go through Phase1 will begin with a Phase 2 baseline visit following screening.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adolescent Schizophrenia

Intervention

Aripiprazole

Status

Not yet recruiting

Source

Otsuka Pharmaceutical Development & Commercialization, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:05:45-0400

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Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...


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