Schizophrenia Clinical Trial
Official title:
A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia
This will be a randomized, double-blind, placebo-controlled study consisting of a screening
period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind
maintenance treatment phase (Phase 3), and a follow up period.
Subjects may be either outpatients or inpatients between screening and through the time they
reach stabilization at the end of Phase 2; hospitalization is not a study requirement.
However, eligible subjects must be outpatients at the beginning of Phase 3.
Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and
3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be
encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any
tolerability issues. The investigator will also have the option to phone the subjects and
their guardian(s) at any time to ensure clinical stability.
A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing
the interim analysis. One interim analysis is planned after 75% of the total expected number
of impending relapse events (28 events) are achieved and will be conducted by an independent
data analysis center. The DMC will make a recommendation about stopping or continuing the
study based on safety and efficacy reviews. The results of the interim analysis and
individual subject data will remain blinded to the sponsor during the course of the study
until the DMC determines that the study will conclude based on the results of the interim
analysis, or the study is completed after 37 endpoint events.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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