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RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders Clinical research trials and RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders. RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders clinical trial. Human subjects often get the best healthcare possible for their RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders  RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
For Condition: Child Development Disorders, Pervasive,Autistic Disorder,Asperger Syndrome
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to compare the safety and effectiveness of medication treatment alone to medication treatment in combination with a structured parent management training program for children with pervasive developmental disorders (PDDs).
Details: 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, aripriprizole. 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. Adaptive and behavioral outcomes are assessed during the study and at a 1 year follow-up visit.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 4 Years/13 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Autistic Disorder, Aspergers'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
Total Enrollment: 120
Location and Contact Information:
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Kristy Hall 614-292-3698
Indiana University *Not yet recruiting*
Indianapolis, Indiana, 46202
United States
Not yet recruiting Arlene Kohn 317-274-8162
Yale University *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting Allison Lancor 203-785-6669
Additional Information:
Study ID Numbers: U10 MH66764; U10 MH66766,U10 MH66768
Study Start Date: February 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080145
Other Autistic Disorder Studies:
1. RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
Related Studies:
Other Autistic Disorder Clinical Trials
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RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
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