The RUPP-PI at Indiana University School of Medicine will capitalize on the site's expertise and experience in pediatric psychopharmacology. In addition, the site will provide training opportunities for young investigators in the neuropsychopharmacology of serious childhood-onset disorders. The proposed treatment protocol will be a 16-week, randomized study of risperidone alone (n=40) vs. risperidone plus a structured behavior therapy program (n=80) in 120 children and adolescents with autistic disorder (autism) and other pervasive developmental disorders (PDDs) who have significant tantrums, aggression, and/or self- injury. Change in these maladaptive behaviors, as well as improvement in adaptive functioning will be determined. Following an additional 8 weeks of stabilization, subjects who show a positive response to combined risperidone plus behavior therapy (estimated sample size of 60) will be randomized to continued treatment with risperidone or gradual discontinuation. The goal of the discontinuation phase is to determine whether the addition of behavior therapy allows for the discontinuation of risperidone. In a previous RUPP Autism Network study, we showed that risperidone was safe and more efficacious than placebo for treating tantrums, aggression, and/or self-injury in children and adolescents with autism. We also demonstrated that these symptoms returned rapidly in the majority of subjects when the risperidone was withdrawn in a placebo-controlled discontinuation phase. The present study will extend these findings and determine if the combination of risperidone and behavior therapy will enhance adaptive functioning in these children and protect against relapse. Side effects and therapeutic response will be carefully monitored. Subjects will be genotyped to explore the relationship between specific serotonin receptor genotypes and treatment response. The proposed study will be conducted by a multisite network that has already shown the capacity to collaborate on the design and conduct of clinical trials in children and adolescents with autism and other PDDs. Furthermore, this five-site network has established reliability on several measures that are relevant to the conduct of clinical trials in this patient population. The RUPP-PI at Indiana University is also prepared to participate in treatment studies involving children and adolescents with other psychiatric disorders. ? ? ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10MH066766-05
Application #
7118929
Study Section
Special Emphasis Panel (ZMH1-CRB-J (03))
Program Officer
Delcarmen-Wiggins, Rebecca
Project Start
2002-09-15
Project End
2008-07-31
Budget Start
2006-08-01
Budget End
2008-07-31
Support Year
5
Fiscal Year
2006
Total Cost
$504,905
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Psychiatry
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
Criado, Kristen K; Sharp, William G; McCracken, Courtney E et al. (2017) Overweight and obese status in children with autism spectrum disorder and disruptive behavior. Autism :1362361316683888
Scahill, Lawrence; Jeon, Sangchoon; Boorin, Susan J et al. (2016) Weight Gain and Metabolic Consequences of Risperidone in Young Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry 55:415-23
Carroll, Devon; Hallett, Victoria; McDougle, Christopher J et al. (2014) Examination of aggression and self-injury in children with autism spectrum disorders and serious behavioral problems. Child Adolesc Psychiatr Clin N Am 23:57-72
Scahill, Lawrence; Dimitropoulos, Anastasia; McDougle, Christopher J et al. (2014) Children's Yale-Brown obsessive compulsive scale in autism spectrum disorder: component structure and correlates of symptom checklist. J Am Acad Child Adolesc Psychiatry 53:97-107.e1
Correia, Catarina; Oliveira, Guiomar; Vicente, Astrid M (2014) Protein interaction networks reveal novel autism risk genes within GWAS statistical noise. PLoS One 9:e112399
Gaugler, Trent; Klei, Lambertus; Sanders, Stephan J et al. (2014) Most genetic risk for autism resides with common variation. Nat Genet 46:881-5
Scahill, Lawrence; Hallett, Victoria; Aman, Michael G et al. (2013) Brief Report: social disability in autism spectrum disorder: results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network trials. J Autism Dev Disord 43:739-46
Handen, Benjamin L; Johnson, Cynthia R; Butter, Eric M et al. (2013) Use of a Direct Observational Measure in a Trial of Risperidone and Parent Training in Children with Pervasive Developmental Disorders. J Dev Phys Disabil 25:355-371
Hallett, Victoria; Lecavalier, Luc; Sukhodolsky, Denis G et al. (2013) Exploring the manifestations of anxiety in children with autism spectrum disorders. J Autism Dev Disord 43:2341-52
Nurmi, E L; Spilman, S L; Whelan, F et al. (2013) Moderation of antipsychotic-induced weight gain by energy balance gene variants in the RUPP autism network risperidone studies. Transl Psychiatry 3:e274

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