Study of Aripiprazole to Treat Children and Adolescents With Autism (PAIRS)

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome

Treatments: Drug: aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00619190

04-1792 GCRC-2491

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 30 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

open aripipraprazole

Experimental group

Description:

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

Treatment:

Drug: aripiprazole

no medication control

No Intervention group

Description:

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