Study of Aripiprazole to Treat Children and Adolescents With Autism

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

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Detailed Description

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The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.

Conditions

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Autistic Disorder Asperger Syndrome Autism Spectrum Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open aripipraprazole

Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg

Group Type EXPERIMENTAL

aripiprazole

Intervention Type DRUG

aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months

no medication control

group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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aripiprazole

aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
* Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
* Have a guardian who is able and willing to give written informed consent
* If competent, subject able and willing to give written assent for their own participation
* If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
* Subjects may receive other nonpharmacologic treatment including dietary treatments

Exclusion Criteria

* Diagnosis of Rett's syndrome or Child Disintegrative Disorder
* Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
* Previous trial of aripiprazole
* Pregnant or nursing
* Epilepsy or another significant chronic medical illness

Minimum Eligible Age

30 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No