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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00080145 |
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 |
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Child Development Disorders, Pervasive |
Drug: Risperidone Behavioral: Behavior Therapy Drug: Aripiprazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder |
Enrollment: | 124 |
Study Start Date: | February 2004 |
Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 4 Years to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | U10 MH66764, U10 MH66766, U10 MH66768, DDTR BD-DD |
Study First Received: | March 24, 2004 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00080145 |
Health Authority: | United States: Federal Government |
Autistic Disorder Asperger Syndrome |
Developmental Disabilities Child Development Disorders, Pervasive Dopamine Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Asperger Syndrome Risperidone Aripiprazole Serotonin |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |