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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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Aripiprazole in Adolescents With Schizophrenia

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PubMed Articles [2142 Associated PubMed Articles listed on BioPortfolio]

Can Aripiprazole Worsen Psychosis in Schizophrenia? A Meta-Analysis of Double-Blind, Randomized, Controlled Trials.

Numerous case reports have reported psychotic worsening when switching to or adding aripiprazole in patients with schizophrenia. The risk of psychotic worsening related to aripiprazole was evaluated t...

The effects of brexpiprazole and aripiprazole on body weight as monotherapy in patients with schizophrenia and as adjunctive treatment in patients with major depressive disorder: an analysis of short-term and long-term studies.

The aim of this analysis was to explore the effects of brexpiprazole and aripiprazole on body weight when used as monotherapy to treat schizophrenia and as adjunctive treatment to antidepressant treat...

Efficacy and safety of aripiprazole for the treatment of schizophrenia: an overview of systematic reviews.

To conduct an overview to summarize the efficacy and safety of aripiprazole for the treatment of schizophrenia.

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Nonadherence to antipsychotic medications for the treatment of schizophrenia is a widely recognized concern, leading to poorer clinical outcomes and higher treatment costs. Long-acting injectable (LAI...

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Epigenetic modification including DNA methylation may affect pathophysiology and the response to antipsychotic drugs in patients with schizophrenia. The objective of the present study was to investiga...

Medical and Biotech [MESH] Definitions

Any observable response or action of an adolescent.

An adolescent who is receiving long-term in-patient services or who resides in an institutional setting.

Adolescent hospitalized for short term care.

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

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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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