A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Phase 3
Completed
- Conditions
- Autistic Disorder
- Interventions
- Registration Number
- NCT01617447
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo of Aripiprazole administered orally once daily Aripiprazole Aripiprazole administered orally once daily
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score 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.
- Secondary Outcome Measures
Name Time Method