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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00080145
First Posted: March 25, 2004
Last Update Posted: August 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Denis Sukhodolsky, Yale University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Denis Sukhodolsky, Yale University:

Primary Outcome Measures:
  • Home Situations Questionnaire [ Time Frame: Week 24 ]
  • Vineland Daily Living Skills Scale [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • Irritability subscale-Aberrant Behavioral Checklist [ Time Frame: Week 24 ]
  • Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Week 24 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
  More Information

Publications:
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: U10MH066764 ( U.S. NIH Grant/Contract )
U10MH066766 ( U.S. NIH Grant/Contract )
U10MH066768 ( U.S. NIH Grant/Contract )
DDTR BD-DD
First Submitted: March 24, 2004
First Posted: March 25, 2004
Last Update Posted: August 16, 2013
Last Verified: August 2013

Keywords provided by Denis Sukhodolsky, Yale University:
Autistic Disorder
Asperger Syndrome

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Disease
Autistic Disorder
Autism Spectrum Disorder
Developmental Disabilities
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents