Pervasive Developmental Disorders (PDDs) are serious developmental conditions affecting 6 per 1000 school-age children. We propose a multisite study in which 120 children with PDDs accompanied by highly irritable behavior will be randomly assigned to risperidone only (N=40) or risperidone plus a structured behavior therapy program (N=80) and compared on adaptive and behavioral outcomes after 16 weeks. After an additional eight weeks of stabilization (6 months total), children who show a positive response to the combination of risperidone and behavior therapy (estimated samples size of 60) will be randomized to continued treatment with risperidone or gradual discontinuation. The goal of the discontinuation phase is to examine whether the addition of behavior therapy permits discontinuation of risperidone without relapse. PDD can be a profound disability across social, emotional, and academic domains. Thus, there is a pressing need for new treatments in PDD that are safe and effective. In a previous RUPP Autism Network study, we showed that risperidone was safe and effective for children and adolescents with autism accompanied by tantrums, aggression, and/or self-injury. We also showed that the behavioral symptoms rapidly returned in a high percentage of these pediatric patients when the medication was withdrawn in a placebo-controlled discontinuation study. The present study will extend these findings and will test whether risperidone plus behavior therapy will enhance adaptive functioning in children with PDDs and protect against relapse. Side effects and therapeutic response will be carefully monitored. Subjects will be genotyped in order to evaluate the relationship of 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 in the design and conduct of clinical trials in the PDD population. Furthermore, this five-site network has established reliability on several measures relevant to the multi-site clinical trials in children with PDD. O.S.U. also plans two pilot studies: (a) a randomized clinical trial in 60 children with PDDs and severe ADHD behavior and (b) a study of ziprasidone in 30 children and adolescents with PDDs and highly irritable behaviors.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10MH066768-01
Application #
6554732
Study Section
Special Emphasis Panel (ZMH1-CRB-J (03))
Program Officer
Wagner, Ann
Project Start
2002-09-01
Project End
2007-07-31
Budget Start
2002-09-01
Budget End
2003-07-31
Support Year
1
Fiscal Year
2002
Total Cost
$504,185
Indirect Cost
Name
Ohio State University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
098987217
City
Columbus
State
OH
Country
United States
Zip Code
43210
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
Calarge, Chadi A; Ziegler, Ekhard E; Del Castillo, Nicole et al. (2015) Iron homeostasis during risperidone treatment in children and adolescents. J Clin Psychiatry 76:1500-5
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
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
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
Arnold, L Eugene; Aman, Michael G; Li, Xiaobai et al. (2012) Research Units of Pediatric Psychopharmacology (RUPP) autism network randomized clinical trial of parent training and medication: one-year follow-up. J Am Acad Child Adolesc Psychiatry 51:1173-84

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