A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

February 28, 2017 updated by: Otsuka Pharmaceutical Co., Ltd.

A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu Region, Japan
      • Chugoku Region, Japan
      • Kanto Region, Japan
      • Kinki Region, Japan
      • Kyushu Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.
  • Inpatient or outpatient status
  • Others

Exclusion Criteria:

  • The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
  • Patients who fall under a contraindication listed in the ABILIFY package insert
  • Others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
administered orally once daily
Drug: Placebo of Aripiprazole
administered orally once daily
EXPERIMENTAL: Aripiprazole
administered orally once daily
Drug: Aripiprazole
Flexibly dose administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
Time Frame: baseline, 8 weeks after dosing
The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.
baseline, 8 weeks after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (ESTIMATE)

June 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 031-11-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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