A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Otsuka

Status and phase: Completed; Phase 3

Conditions: Autistic Disorder

Treatments: Drug: Placebo of Aripiprazole; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01617447

031-11-002

Details and patient eligibility

About

The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder

Enrollment: 92 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Inpatient or outpatient status
• Others

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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

administered orally once daily

Treatment:

Drug: Placebo of Aripiprazole

Aripiprazole

Experimental group

Description:

administered orally once daily

Treatment:

Drug: Aripiprazole