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Completed

NCT Number: NCT00080145

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

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.

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Key information

Conditions

Child Development Disorders, Pervasive Asperger Syndrome Autism Spectrum Disorder Autistic Disorder Mental Disorders Neurodevelopmental Disorders

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

Behavior Therapy

Behavioral

Primary outcomes

  1. Home Situations Questionnaire

    Time frame: Week 24

  2. Vineland Daily Living Skills Scale

    Time frame: Week 24

Secondary outcomes

  1. Irritability subscale-Aberrant Behavioral Checklist

    Time frame: Week 24

  2. Clinical Global Impressions-Improvement (CGI-I)

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 25, 2004
Registry last updated
Aug 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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