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Child Behavior Disorders |
Bullying |
Clinical Trial: RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to compare the safety and effectiveness of medication treatment alone to medication treatment in combination with a structured parent management training program for children with pervasive developmental disorders (PDDs).
| Condition | Treatment or Intervention |
|---|---|
| Child Development Disorders, Pervasive Autistic Disorder Asperger Syndrome | Drug: Risperidone Behavior: Behavior Therapy Drug: Aripriprizole |
MedlinePlus related topics: Asperger's Syndrome; Autism; Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Risperidone and Behavioral Therapy in Treatment of Children and Adolescents with Autistic Disorder
Expected Total Enrollment: 120
Study start: February 2004; Expected completion: September 2007
Data entry closure: July 2007
PDD can be a profoundly disabling condition across social, emotional, and academic domains. Safe and effective treatments for PDD are needed.
Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks. Participants who show deterioration at Week 4 will be offered an alternative mediation treatment, aripriprizole. These participants will remain in their original treatment group (either med alone or med plus parent management training). After 6 months of treatment (Week 24), participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment. Adaptive and behavioral outcomes are assessed during the study and at a 1 year follow-up visit.
Eligibility
Ages Eligible for Study: 4 Years - 13 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder not otherwise specified
- Weight > 30 lbs
- IQ >= 35 or mental age of at least 18 months
Exclusion Criteria:
- Psychotic Disorder
- History of intolerance or nonresponse to risperidone
- Pregnancy
- History of neuroleptic malignant syndrome
Location and Contact Information
Connecticut
Yale University, New Haven, Connecticut, 06520, United States; Recruiting
Larry Scahill, PhD, Principal Investigator
Indiana
Indiana University, Indianapolis, Indiana, 46202, United States; Not yet recruiting
Marianna Zaphiriou 317-278-6253 mzaphiri@iupui.edu
Christopher McDougle, MD, Principal Investigator
Ohio
Ohio State University, Columbus, Ohio, 43210, United States; Recruiting
Lorelei Ark 614-292-7022 ark.7@osu.edu
Michael Aman, PhD, Principal Investigator
Eugene Arnold, MD, Sub-Investigator
More Information
Publications
McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG, Arnold LE, Lindsay R, Nash P, Hollway J, McDougle CJ, Posey D, Swiezy N, Kohn A, Scahill L, Martin A, Koenig K, Volkmar F, Carroll D, Lancor A, Tierney E, Ghuman J, Gonzalez NM, Grados M, Vitiello B, Ritz L, Davies M, Robinson J, McMahon D. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug 1;347(5):314-21.
Scahill L, McCracken J, McDougle CJ, Aman M, Arnold LE, Tierney E, Cronin P, Davies M, Ghuman J, Gonzalez N, Koenig K, Lindsay R, Martin A, McGough J, Posey DJ, Swiezy N, Volkmar F, Ritz L, Vitiello B. Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism. J Child Adolesc Psychopharmacol. 2001 Winter;11(4):377-88.
McDougle CJ, Scahill L, McCracken JT, Aman MG, Tierney E, Arnold LE, Freeman BJ, Martin A, McGough JJ, Cronin P, Posey DJ, Riddle MA, Ritz L, Swiezy NB, Vitiello B, Volkmar FR, Votolato NA, Walson P. Research Units on Pediatric Psychopharmacology (RUPP) Autism Network. Background and rationale for an initial controlled study of risperidone. Child Adolesc Psychiatr Clin N Am. 2000 Jan;9(1):201-24. Review.
Record last reviewed: November 2004
Last Updated: November 9, 2004
Record first received: March 24, 2004
ClinicalTrials.gov Identifier: NCT00080145
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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