This K23 Award focuses on the psychopharmacology of pervasive developmental disorders (PDDs). Despite numerous treatment studies in autistic disorder (autism), research specifically focused on the diagnostic subtype of FDD not otherwise specified (NOS) is greatly lacking. In fact, there have been no published double-blind, placebo-controlled trials of any drug specific to this disorder. Moreover, recent epidemiological research has found that PDD NOS is the most common subtype of PDD. Therefore, it is critically important that pharmacologic research on PDDs other than autism be conducted. Often considered "higher functioning", these children suffer from severe lifelong impairments in core social skills and frequently associated irritability. Symptoms of irritability, including aggression, tantrums, and self- injury, can be more serious than those seen in autism. The candidate's long-term objective is to determine the most effective and safe pharmacologic treatments for PDDs, specifically PDD NOS.
Her aims for this K23 Award are: (1) to develop an in depth understanding of clinical research and psychopharmacology by conducting a treatment study in PDD NOS;and (2) to obtain a Master of Science in Clinical Research degree at Indiana University, focusing on courses including research ethics, biostatistics, and research methodology. She will work closely with her mentor, Christopher J. McDougle, M.D., an international expert in the pharmacotherapy of PDDs, to accomplish these aims and transition into her career as an independent investigator. This proposal is a double-blind, placebo-controlled and open-label continuation study of aripiprazole for irritability in 60 children and adolescents with PDD NOS. Pilot data from the applicant suggests that aripiprazole is effective for targeting symptoms of irritability commonly observed in PDD NOS, including aggression, tantrums, and self-injury. Relevance: PDD NOS is a highly prevalent disorder often associated with severe irritability that impedes participation in educational, therapeutic, and vocational programs, with escalating costs of care. Thus, the development of safe and effective pharmacotherapies that improve irritability is clearly relevant to public health.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23MH082119-05
Application #
8278007
Study Section
Interventions Committee for Disorders Involving Children and Their Families (ITVC)
Program Officer
Gilotty, Lisa
Project Start
2008-09-24
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
5
Fiscal Year
2012
Total Cost
$182,830
Indirect Cost
$13,543
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
Stigler, Kimberly A (2014) Psychopharmacologic management of serious behavioral disturbance in ASD. Child Adolesc Psychiatr Clin N Am 23:73-82
Kowalski, Janet L; Wink, Logan K; Blankenship, Kelly et al. (2011) Paliperidone palmitate in a child with autistic disorder. J Child Adolesc Psychopharmacol 21:491-3
Erickson, Craig A; Stigler, Kimberly A; Wink, Logan K et al. (2011) A prospective open-label study of aripiprazole in fragile X syndrome. Psychopharmacology (Berl) 216:85-90
Erickson, Craig A; Early, Maureen; Stigler, Kimberly A et al. (2011) An open-label naturalistic pilot study of acamprosate in youth with autistic disorder. J Child Adolesc Psychopharmacol 21:565-9
Stigler, Kimberly A; McDonald, Brenna C; Anand, Amit et al. (2011) Structural and functional magnetic resonance imaging of autism spectrum disorders. Brain Res 1380:146-61
Blankenship, Kelly; Erickson, Craig A; Stigler, Kimberly A et al. (2011) Guanfacine extended release in two patients with pervasive developmental disorders. J Child Adolesc Psychopharmacol 21:287-90
Erickson, Craig A; Weng, Ning; Weiler, Ivan Jeanne et al. (2011) Open-label riluzole in fragile X syndrome. Brain Res 1380:264-70
Scahill, Lawrence; Aman, Michael G; McDougle, Christopher J et al. (2009) Trial design challenges when combining medication and parent training in children with pervasive developmental disorders. J Autism Dev Disord 39:720-9