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

NCT01942148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-06-28

Study results available
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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).

Conditions

Interventions

DRUG

Aripiprazole

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyoji Imaoka, Mr · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Japan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942148 on ClinicalTrials.gov