RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders

Child Development Disorders, Pervasive Clinical Trial

Official title:

Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080145
• Other study ID #: U10MH066764
• Secondary ID: U10MH066764U10MH
• Status: Completed
• Phase: N/A
• First received: March 24, 2004
• Last updated: August 15, 2013
• Start date: February 2004
• Est. completion date: September 2007

Study information

• Verified date: August 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.

Description:

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, aripiprazole. 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 (This phase of the study was ended in Nov. 2006) Adaptive and behavioral outcomes are assessed during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 13 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities

Intervention

Drug:
• Risperidone

Behavioral:
• Behavior Therapy

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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; Research Units on Pediatric Psychopharmacology Autism Network. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug 1;347(5):314-21. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Home Situations Questionnaire		Week 24	No
Primary	Vineland Daily Living Skills Scale		Week 24	Yes
Secondary	Irritability subscale-Aberrant Behavioral Checklist		Week 24
Secondary	Clinical Global Impressions-Improvement (CGI-I)		Week 24	No