A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
- Registration Number
- NCT01617460
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aripiprazole Aripiprazole administered orally once daily
- Primary Outcome Measures
Name Time Method Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score 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.
- Secondary Outcome Measures
Name Time Method