Clinical trial NCT00619190: Study of Aripiprazole to Treat Children and Adolescents With Autism
Official title: An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autistic Disorder
Asperger Syndrome
Autism Spectrum Disorder
Keywords: open label
aripiprazole
children
adolescents
autism spectrum disorders
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Clinical Global Impressions Scale - Severity Score (CGI-S)
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Department of Psychiatry
state: North Carolina
Study officials:
affiliation: University of North Carolina, Department of Psychiatry
name: Linmarie Sikich, MD
role: PRINCIPAL_INVESTIGATOR
References: