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A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)

NCT01942148•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).

Eligibility

Age

13 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR
•Male and female patients aged 13-17 years
•Patients completing the 031-09-003 study
•Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
•Inpatient or outpatient status

Exclusion Criteria

•Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
•Patients who have been compulsorily admitted to hospital
•Patients with mental retardation
•Patients with thyroid disorder
•Patients who fall under a contraindication listed in the ABILIFY package insert
•Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
•Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
•Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5%
•Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
•Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
+6 more criteria

Locations (8)

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kansai Region, Japan

Kanto Region, Japan

Kyushu Region, Japan

Shikoku Region, Japan

Tohoku Region, Japan

Key Dates

Start Date

August 1, 2010

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

June 28, 2017

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

Aripiprazole

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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