A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Phase 3
- Conditions
- Autistic Disorder, Children and Adolescents
- Registration Number
- JPRN-jRCT2080221820
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1) The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
2) The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
3) Inpatient or outpatient status
4) Othress
Exclusion Criteria
1) The patient is currently diagnosed with another disorder on the autism spectrum in DSMIV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
2) Patients who fall under a contraindication listed in the ABILIFY package insert
3) Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method