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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Denis Sukhodolsky, Yale University
ClinicalTrials.gov Identifier:
NCT00080145
First received: March 24, 2004
Last updated: August 15, 2013
Last verified: August 2013

March 24, 2004
August 15, 2013
February 2004
September 2007   (final data collection date for primary outcome measure)
  • Home Situations Questionnaire [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Vineland Daily Living Skills Scale [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00080145 on ClinicalTrials.gov Archive Site
  • Irritability subscale-Aberrant Behavioral Checklist [ Time Frame: Week 24 ]
  • Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Child Development Disorders, Pervasive
  • Drug: Risperidone
  • Behavioral: Behavior Therapy
  • Active Comparator: risperidone plus parent management training
    Interventions:
    • Drug: Risperidone
    • Behavioral: Behavior Therapy
  • Active Comparator: risperidone only
    Intervention: Drug: Risperidone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
4 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00080145
U10 MH66764, U10MH066764, U10 MH66766, U10 MH66768, DDTR BD-DD
Yes
Denis Sukhodolsky, Yale University
Yale University
National Institute of Mental Health (NIMH)
Not Provided
Yale University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP