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
  Purpose

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.


Condition Intervention
Child Development Disorders, Pervasive
Drug: Risperidone
Behavioral: Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Irritability subscale-Aberrant Behavioral Checklist [ Time Frame: Week 24 ]
  • Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: February 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: risperidone plus parent management training Drug: Risperidone Behavioral: Behavior Therapy
Active Comparator: risperidone only Drug: Risperidone

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.

  Eligibility

Ages Eligible for Study:   4 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080145

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Yale University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denis Sukhodolsky, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00080145     History of Changes
Other Study ID Numbers: U10 MH66764, U10MH066764, U10 MH66766, U10 MH66768, DDTR BD-DD
Study First Received: March 24, 2004
Last Updated: August 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Autistic Disorder
Asperger Syndrome

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Autistic Disorder
Developmental Disabilities
Mental Disorders Diagnosed in Childhood
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 18, 2014