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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Autistic Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01617460

031-11-003

Details and patient eligibility

About

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).

Enrollment: 86 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Aripiprazole

Experimental group

Description:

administered orally once daily

Treatment:

Drug: Aripiprazole