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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.
 
ClinicalTrials.gov Identifier: NCT01617447
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE June 12, 2012
Results First Submitted Date  ICMJE January 4, 2017
Results First Posted Date  ICMJE April 11, 2017
Last Update Posted Date April 11, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
Aberrant behavior checklist Japanese version (ABC-J) Irritability subscale score [ Time Frame: baseline, 8 weeks after dosing ]
Mean change (LOCF) from baseline in ABC-J Irritability subscale score at 8 weeks after dosing.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Official Title  ICMJE A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autistic Disorder
Intervention  ICMJE
  • Drug: Placebo of Aripiprazole
    administered orally once daily
  • Drug: Aripiprazole
    Flexibly dose administered orally once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    administered orally once daily
    Intervention: Drug: Placebo of Aripiprazole
  • Experimental: Aripiprazole
    administered orally once daily
    Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
92
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01617447
Other Study ID Numbers  ICMJE 031-11-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kyoji Imaoka, Mr Otsuka Pharmaceutical Co., Ltd.
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP