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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01617447
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Autistic Disorder Drug: Placebo of Aripiprazole Drug: Aripiprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01617447     History of Changes
Other Study ID Numbers: 031-11-002
First Posted: June 12, 2012    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017

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

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