NCT00080145

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 4 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Child Development Disorders, Pervasive

Interventions

Type	Name	Description
DRUG	Risperidone
BEHAVIORAL	Behavior Therapy

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2004-03-25
• Last updated: 2013-08-16

Locations

3 sites across 1 country: United States