Study of Aripiprazole to Treat Children and Adolescents With Autism - Full Text View

Sponsor:	University of North Carolina, Chapel Hill
Collaborator:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Linmarie Sikich, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00619190

Purpose

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.

Condition	Intervention	Phase
Autistic Disorder Asperger Syndrome Autism Spectrum Disorder	Drug: aripiprazole	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:

MedlinePlus related topics: Asperger's Syndrome Autism

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Clinical Global Impressions Scale - Improvement Score (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Parent report forms (especially the Pervasive Developmental Disorders Behavioral Inventory - parent report (PDDBI-p)) [ Time Frame: 12 weeks, 12 months ] [ Designated as safety issue: No ]
Safety Monitoring Uniform Reporting Form for STAART (SMURF, Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Laboratory Assessments [ Time Frame: 12 weeks, 12 months ] [ Designated as safety issue: Yes ]
Physical Exam [ Time Frame: 12 weeks, 12 months ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: 12 weeks, 12 months ] [ Designated as safety issue: Yes ]
Clinical Global Impressions - Improvement Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: open aripipraprazole Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	Drug: aripiprazole aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months Other Name: Abilify
No Intervention: 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. They may receive behavioral interventions

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

Ages Eligible for Study:	30 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619190

Locations

United States, North Carolina
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, United States, 27514

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Bristol-Myers Squibb

Investigators

Principal Investigator:

Linmarie Sikich, MD

University of North Carolina, Department of Psychiatry

More Information

No publications provided

Responsible Party:	Linmarie Sikich, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00619190 History of Changes
Other Study ID Numbers:	04-1792 GCRC-2491
Study First Received:	February 7, 2008
Last Updated:	December 16, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

open label
aripiprazole
children
adolescents
autism spectrum disorders

Additional relevant MeSH terms:

Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2012