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

This study is currently recruiting participants.
Verified December 2012 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01617447
First received: June 8, 2012
Last updated: December 9, 2012
Last verified: December 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Autism
U.S. FDA Resources

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 2015
Estimated Primary Completion Date: June 2015 (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

  Eligibility

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

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

Contacts
Contact: Drug Information Center +81-3-6361-7314

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

No publications provided

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: December 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Autistic Disorder, children and adolescents
Aripiprazole
Double-blind
Randomized
children and adolescents

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013