A Long-term, Extended 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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-10-31

Brief Summary

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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).

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aripiprazole

administered orally once daily

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Flexibly dose administered orally once daily

Interventions

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Aripiprazole

Flexibly dose administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No