Abstract

The purpose of the contract is to 1) establish qualified clinical research units that, by building of existing research resources at the host Institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies ont he safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and 2) fund selected research projects of particular public health significance, in particular in the area of autism and other pervasive developmental disorders, to be conducted at these units. The units, together with the already funded RUPPs will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including (but not limited to): dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. To establish research units of where clinical studies on the safety, efficacy, pharmacokinetics and pharmacodynamics of psychotropic medications can be investigated in children and adolescents, in general, and in patients suffering from autism and other pervasive developmental disorders in particular. To conduct a minimum of 2 studies at each research unit (of which one shall be a clinical efficacy trial and the other a pharmacokinetic and/or pharmacodynamic dose finding study or a pilot efficacy and tolerability study) during the 3 years of the contract. In addition, if the two year option is exercised, at least another two similar studies (i.e., one efficacy trial and one pharmacokinetic and/or pharmacodynamic dose finding study) shall be conducted. To spur the conduct of other clinical trials and studies in pediatric psychopharmacology to be funded through mechanisms other than this contract (i.e., investigator-initiated grants from federal agencies, private foundations, and pharmaceutical companies).

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research and Development Contracts (N01)
Project #
N01MH070001-000
Application #
2665222
Study Section
Project Start
1997-09-30
Project End
2000-09-30
Budget Start
1997-09-30
Budget End
1998-09-30
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
Indiana University-Purdue University at Indianapolis
Department
Psychiatry
Type
Schools of Medicine
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202

  Publications

Levine, S Z; Kodesh, A; Goldberg, Y et al. (2016) Initial severity and efficacy of risperidone in autism: Results from the RUPP trial. Eur Psychiatry 32:16-20
Aman, Michael; Rettiganti, Mallikarjuna; Nagaraja, Haikady N et al. (2015) Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial. J Child Adolesc Psychopharmacol 25:482-93
McCracken, J T; Badashova, K K; Posey, D J et al. (2014) Positive effects of methylphenidate on hyperactivity are moderated by monoaminergic gene variants in children with autism spectrum disorders. Pharmacogenomics J 14:295-302
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
Tobiasova, Zuzana; van der Lingen, Klaas H B; Scahill, Lawrence et al. (2011) Risperidone-related improvement of irritability in children with autism is not associated with changes in serum of epidermal growth factor and interleukin-13. J Child Adolesc Psychopharmacol 21:555-64
Arnold, L Eugene; Farmer, Cristan; Kraemer, Helena Chmura et al. (2010) Moderators, mediators, and other predictors of risperidone response in children with autistic disorder and irritability. J Child Adolesc Psychopharmacol 20:83-93
Jahromi, Laudan B; Kasari, Connie L; McCracken, James T et al. (2009) Positive effects of methylphenidate on social communication and self-regulation in children with pervasive developmental disorders and hyperactivity. J Autism Dev Disord 39:395-404
Nikolov, Roumen N; Bearss, Karen E; Lettinga, Jelle et al. (2009) Gastrointestinal symptoms in a sample of children with pervasive developmental disorders. J Autism Dev Disord 39:405-13

Showing the most recent 10 out of 17 publications