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Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

NCT01122927 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2016-02-08

Study results available
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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) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.

Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study

Conditions

  • Adolescent Schizophrenia
  • Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Interventions

DRUG

Aripiprazole

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Eva Kohegyi, MD · Otsuka Pharmaceutical Development and Commercialization, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • United States
  • Bulgaria
  • Croatia
  • Hungary
  • India
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • Taiwan
  • Ukraine

Study Locations

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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 NCT01122927 on ClinicalTrials.gov