FindTrial
Sign In

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

A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221820
Enrollment
Unknown
Registered
2012-06-07
Start date
2012-06-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Disorder, Children and Adolescents

Interventions

investigational material(s) Generic name etc : Aripiprazole INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational materia

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Scores of 5 subscales in ABC-J—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026