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

Not Applicable

Completed

• Conditions: Child Development Disorders, Pervasive
• Interventions: Drug: Risperidone; Behavioral: Behavior Therapy

• Registration Number: NCT00080145
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-03-24
• Study First Submitted QC: 2004-03-24
• Study First Posted: 2004-03-25
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-15
• Last Update Posted: 2013-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
risperidone plus parent management training	Risperidone	-
risperidone plus parent management training	Behavior Therapy	-
risperidone only	Risperidone	-

Primary Outcome Measures

Name	Time	Method
Home Situations Questionnaire	Week 24
Vineland Daily Living Skills Scale	Week 24

Secondary Outcome Measures

Name	Time	Method
Irritability subscale-Aberrant Behavioral Checklist	Week 24
Clinical Global Impressions-Improvement (CGI-I)	Week 24

Trial Locations

Locations (3)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States