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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617447
• Other study ID #: 031-11-002
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2012
• Last updated: October 25, 2016
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Disease

Intervention

Drug:
• Placebo of Aripiprazole
administered orally once daily
• Aripiprazole
Flexibly dose administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant behavior checklist Japanese version (ABC-J) Irritability subscale score	Mean change (LOCF) from baseline in ABC-J Irritability subscale score at 8 weeks after dosing.	baseline, 8 weeks after dosing	No