Clinical Trial: RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder
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 Summary:
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.
Sponsor: Yale University
Current Primary Outcome:
- Home Situations Questionnaire [ Time Frame: Week 24 ]
- Vineland Daily Living Skills Scale [ Time Frame: Week 24 ]
Original Primary Outcome:
Current Secondary Outcome:
- Irritability subscale-Aberrant Behavioral Checklist [ Time Frame: Week 24 ]
- Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Week 24 ]
Original Secondary Outcome:
Information By: Yale University
Dates:
Date Received: March 24, 2004
Date Started: February 2004
Date Completion:
Last Updated: August 15, 2013
Last Verified: August 2013
