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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Autistic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

administered orally once daily

Group Type PLACEBO_COMPARATOR

Placebo of Aripiprazole

Intervention Type DRUG

administered orally once daily

Aripiprazole

administered orally once daily

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Flexibly dose administered orally once daily

Interventions

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Placebo of Aripiprazole

administered orally once daily

Intervention Type DRUG

Aripiprazole

Flexibly dose administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No