Trial record 20 of 54 for:
"Asperger Syndrome"
Study of Aripiprazole to Treat Children and Adolescents With Autism (PAIRS)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00619190
First received: February 7, 2008
Last updated: January 18, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
Asperger syndrome
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 ]
| Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2012 |
| 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, MD, 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: | January 18, 2013 |
| 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:
|
Asperger Syndrome Autistic Disorder 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 June 18, 2013