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A short treatment study of aripiprazole in pediatric patients with Autistic Disorder

A short-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-jRCT2080221819
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 current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. 2) Inpatient or outpatient status 3) Othres

Exclusion criteria

Exclusion criteria: 1) 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. 2) Patients who fall under a contraindication listed in the ABILIFY package insert 3) Others

Design outcomes

Primary

MeasureTime frame
ABC-J Irritability subscale score Mean change (LOCF) from baseline in ABC-J Irritability subscale score at 8 weeks after dosing.—

Outcome results

None listed

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