This Mentored Patient-Oriented Research Career Development Award (K23) focuses on the psychopharmacologic treatment of autism and related pervasive developmental disorders (PDDs). Autism and other PDDs are increasingly being diagnosed and are the source of serious lifelong disability. Despite investigations into the pharmacologic treatment of autism, no drugs have been proven to consistently improve the core symptoms of the disorder, namely social and communication impairment. The principal investigator's long-term career goal is to determine the best and most effective pharmacologic treatments for autism and related disorders. The principal investigator's specific aims are to expand his knowledge of psychopharmacology and clinical research by conducting controlled treatment studies in autism. After this training, the principal investigator will have the necessary skills to launch his career as an independent investigator in this field. To accomplish these goals, the principal investigator will work closely with his mentor, Christopher J. McDougle, M.D., an expert in the pharmacotherapy of these disorders, in implementing the research plan. Specifically, the research plan includes a double-blind, placebo-controlled study of D-cycloserine for the treatment of social withdrawal associated with autism. Pilot data has suggested that D-cycloserine, a drug that affects the N-methyI-D-aspartate (NMDA) subtype of glutamate receptor, has efficacy for the symptom of social withdrawal in autism. This project proposes to study the efficacy and safety of D-cycloserine in 60 children and adolescents with autism. Also integral to this award will be dedicated time focused on didactic courses in the following areas: advanced psychopharmacologic principles, clinical research methodology, biostatistics, research ethics, epidemiology, writing and presentation skills, and grant preparation. This curriculum will lead to a Master of Science in Clinical Research degree offered by Indiana University. Augmenting this coursework, will be additional consultation with experts in the field, attendance and presentations at national scientific meetings, training in behavioral measures necessary for clinical trials in autism, and additional coursework and seminars in neuropsychopharmacology and preclinical research. Towards the later years of the award, the candidate will have performed additional studies and applied for independent research funding.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23MH068627-04
Application #
7060364
Study Section
Interventions Research Review Committee (ITV)
Program Officer
Gilotty, Lisa
Project Start
2003-08-01
Project End
2008-04-30
Budget Start
2006-05-01
Budget End
2007-04-30
Support Year
4
Fiscal Year
2006
Total Cost
$180,296
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; Bearss, Karen; Sarhangian, Rena et al. (2017) Using a Patient-Centered Outcome Measure to Test Methylphenidate Versus Placebo in Children with Autism Spectrum Disorder. J Child Adolesc Psychopharmacol 27:125-131
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
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
Stigler, Kimberly A; Diener, Jonathan T; Kohn, Arlene E et al. (2009) Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study. J Child Adolesc Psychopharmacol 19:265-74
Posey, David J; Erickson, Craig A; McDougle, Christopher J (2008) Developing drugs for core social and communication impairment in autism. Child Adolesc Psychiatr Clin N Am 17:787-801, viii-ix
McDougle, Christopher J; Stigler, Kimberly A; Erickson, Craig A et al. (2008) Atypical antipsychotics in children and adolescents with autistic and other pervasive developmental disorders. J Clin Psychiatry 69 Suppl 4:15-20
Posey, David J; Stigler, Kimberly A; Erickson, Craig A et al. (2008) Antipsychotics in the treatment of autism. J Clin Invest 118:6-14
Posey, David J; Aman, Michael G; McCracken, James T et al. (2007) Positive effects of methylphenidate on inattention and hyperactivity in pervasive developmental disorders: an analysis of secondary measures. Biol Psychiatry 61:538-44
Posey, David J; McDougle, Christopher J (2007) Guanfacine and guanfacine extended release: treatment for ADHD and related disorders. CNS Drug Rev 13:465-74

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