Developing strategies for psychopharmacological studies in preschool children.
OBJECTIVE
To identify the obstacles and special challenges-ethical, practical, scientific, and regulatory-faced by investigators who attempt to conduct psychopharmacological studies in preschoolers.


METHODS
In a workshop held at the 47th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, featuring interactive sessions designed to elicit discussion of the theory and feasibility of research in this young population, several key domains were identified: diagnosis and assessment, ethics, research design, special considerations for preschoolers, regulatory/industry issues, and education/training.


RESULTS
A Pediatric Psychopharmacology Initiative is needed to consolidate recommendations from this and other workshops and current federal, research, and regulatory committees. A scholarly review and a guide for institutional review boards and investigators should be prepared on issues related to preschoolers. Developmental specialists provide valuable expertise that can strengthen studies of pediatric psychopharmacology. "N of 1" case studies can provide valuable information to clinicians. Only preschoolers with severe symptoms that occur in several interpersonal contexts should be entered into trials. Indications for the study of symptom complexes (e.g., aggression) rather than specific diagnoses should be examined and considered for regulatory activities. Psychopharmacology practice parameters for preschoolers are needed.


CONCLUSIONS
With preschoolers being increasingly treated with psychopharmacological agents, the need for investigations to address the safety and efficacy of these medications is becoming a central issue for researchers from many disciplines.
Greenhill
Laurence L
LL
New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA. LarryLGreenhill@cs.com.
Jensen
Peter S
PS
Abikoff
Howard
H
Blumer
Jeffery L
JL
Deveaugh-Geiss
Joseph
J
Fisher
Celia
C
Hoagwood
Kimberly
K
Kratochvil
Christopher J
CJ
Lahey
Benjamin B
BB
Laughren
Thomas
T
Leckman
James
J
Petti
Theodore A
TA
Pope
Kayla
K
Shaffer
David
D
Vitiello
Beneditto
B
Zeanah
Charles
C
D000293:Adolescent; D002648:Child; D002665:Child Psychiatry / Q000592:standards*; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D012106:Research / Q000592:standards*
D011619:Psychotropic Drugs