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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT00080145
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: February 2004
• Completion date: September 2007