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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Aripiprazole

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

• Others