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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
First received: June 8, 2012
Last updated: November 4, 2015
Last verified: November 2015
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

Condition Intervention Phase
Autistic Disorder
Drug: Placebo of Aripiprazole
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Aberrant behavior checklist Japanese version (ABC-J) Irritability subscale score [ Time Frame: baseline, 8 weeks after dosing ] [ Designated as safety issue: No ]
    Mean change (LOCF) from baseline in ABC-J Irritability subscale score at 8 weeks after dosing.

Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01617447

Chubu Region, Japan
Chugoku Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Study Director: Kyoji Imaoka, Mr Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01617447     History of Changes
Other Study ID Numbers: 031-11-002 
Study First Received: June 8, 2012
Last Updated: November 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Autistic Disorder, children and adolescents
children and adolescents

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Neurodevelopmental Disorders
Antipsychotic Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 24, 2016