A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole
- Conditions
- Autistic Disorder
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 86
- Primary Endpoint
- Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Aripiprazole
administered orally once daily
Intervention: Aripiprazole
Outcomes
Primary Outcomes
Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
Time Frame: Baseline, the final administration
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.