This trial is active, not recruiting.

Condition autistic disorder
Treatment aripiprazole
Phase phase 3
Sponsor Otsuka Pharmaceutical Co., Ltd.
Start date September 2012
End date June 2017
Trial identifier NCT01617460, 031-11-003


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
administered orally once daily
Flexibly dose administered orally once daily

Primary Outcomes

Aberrant behavior checklist Japanese version (ABC-J)
time frame:

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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

Additional Information

Official title A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..