A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
This trial is active, not recruiting.
|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|
|Chubu Region, Japan||not available||no longer recruiting|
|Chugoku Region, Japan||not available||no longer recruiting|
|Kanto Region, Japan||not available||no longer recruiting|
|Kinki Region, Japan||not available||no longer recruiting|
|Kyushu Region, Japan||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
administered orally once daily
Aberrant behavior checklist Japanese version (ABC-J)
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
|Official title||A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder|
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