A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Autistic Disorder Clinical Trial

Official title:

A Long-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: NCT01617460
• Other study ID #: 031-11-003
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2012
• Last updated: May 29, 2017
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.

• The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)

• Inpatient or outpatient status

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

Related Conditions & MeSH terms

• Autistic Disorder
• Disease

Intervention

Drug:
• 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	Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score	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.	Baseline, the final administration