title: Analysis of pediatric clinical drug trials for neuropsychiatric conditions.
abstract: OBJECTIVE
  Neuropsychiatric conditions represent a large and increasing disease burden in children. A number of drugs are available for the treatment of these conditions, but most drugs have not been adequately tested in children, and off-label drug use remains widespread. We sought to define and quantify recent and ongoing clinical research on the use of neuropsychiatric drugs in children.
  
  
  METHODS
  Drug trials registered in ClinicalTrials.gov between 2006 and 2011 and studying neuropsychiatric conditions were selected and classified based on the drug's Food and Drug Administration (FDA) approval status in children. We measured the proportion of trials seeking to expand the use of a drug to pediatric patients and the proportion of available drugs studied in children.
  
  
  RESULTS
  Only 10% of neuropsychiatric trials focused on children. Of 303 drugs studied in both pediatric and adult populations, 90% lacked FDA approval in children and 97% were not approved in children for the indication studied. However, only 19% of all neuropsychiatric drugs were under study in pediatric populations, with as few as 8% of either antidepressant or antipsychotic drugs. Overall, 76% of pediatric drug trials examined a drug previously unapproved in children and 26% explored the use of a drug for a new indication.
  
  
  CONCLUSIONS
  Despite the rising prevalence of neuropsychiatric disease and the paucity of FDA-approved pediatric drugs, only a small proportion of trials focus on pediatric populations and these trials cover only a fraction of available drugs. This deficiency is most pronounced for depression and schizophrenia.
authors: Department of Critical Care, Hospital for Sick Children, Toronto, ON, Canada. sgmurthy@gmail.com
authors: Srinivas
authors: S
authors: Murthy
authors: Kenneth D
authors: KD
authors: Mandl
authors: Florence
authors: F
authors: Bourgeois
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D007223:Infant; D009422:Nervous System Diseases / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents
keywords: neuropsychiatric conditions; off-label drug use; pediatric drug approval; pediatric research
references: Lancet. 1999 Sep;354 Suppl 2:SII21-4
references: 10507255
references: N Engl J Med. 2011 Mar 3;364(9):852-60
references: 21366476
references: Milbank Q. 2011 Sep;89(3):450-502
references: 21933276
references: Arch Gen Psychiatry. 2009 Aug;66(8):848-56
references: 19652124
references: Biol Psychiatry. 2007 Jul 15;62(2):107-14
references: 17306773
references: Arch Intern Med. 2012 Feb 13;172(3):237-44
references: 22332155
references: J Child Adolesc Psychopharmacol. 1998;8(2):87-97
references: 9730074
references: N Engl J Med. 2003 Sep 18;349(12):1157-67
references: 13679531
references: Pharmacoepidemiol Drug Saf. 2010 Feb;19(2):158-74
references: 20049836
references: JAMA. 2003 Aug 20;290(7):905-11
references: 12928467
references: Int J Law Psychiatry. 1982;5(3-4):319-29
references: 6135666
references: Lancet. 2004 Aug 28-Sep 3;364(9436):803-11
references: 15337409
references: Pediatrics. 2012 Mar;129(3):e771-84
references: 22351885
references: Pediatrics. 2012 Aug;130(2):285-92
references: 22826574
references: Br J Clin Pharmacol. 2011 Jun;71(6):929-35
references: 21564161
references: J Child Adolesc Psychopharmacol. 2005 Feb;15(1):26-37
references: 15741783
references: Eur J Clin Pharmacol. 2012 Jul;68(7):1073-7
references: 22307225
references: PLoS Med. 2008 Sep 23;5(9):e191
references: 18816163
references: Clin Ther. 2012 Nov;34(11):S1-10
references: 23149008
references: Arch Pediatr Adolesc Med. 2009 Dec;163(12):1080-6
references: 19996043
references: JAMA. 2012 May 9;307(18):1914-5
references: 22570457
references: BMJ. 2002 Mar 23;324(7339):702
references: 11909786
references: PLoS One. 2012;7(7):e40991
references: 22829905
references: Pharmacoepidemiol Drug Saf. 2012 Feb;21(2):152-60
references: 21793097
references: Expert Opin Drug Saf. 2008 Jan;7(1):9-27
references: 18171311
references: Eur J Clin Pharmacol. 2008 Nov;64(11):1111-8
references: 18685837
references: Ambul Pediatr. 2006 Mar-Apr;6(2):79-83
references: 16530143
references: Arch Pediatr Adolesc Med. 2007 Mar;161(3):282-90
references: 17339510
references: Clin Ther. 2008 Nov;30(11):2133-45
references: 19108801
references: Acad Pediatr. 2009 Mar-Apr;9(2):81-8
references: 19329098
references: JAMA. 1998 Jan 28;279(4):281-6
references: 9450711
references: N Engl J Med. 1999 Jun 17;340(24):1881-7
references: 10369852
references: J Child Adolesc Psychopharmacol. 2012 Feb;22(1):5-10
references: 22251022
references: Pediatrics. 1999 Sep;104(3 Pt 2):644-5
references: 10469808
references: PLoS One. 2011 Feb 24;6(2):e14701
references: 21383991
references: Pediatrics. 2010 May;125(5):876-88
references: 20385637
references: Eur J Pediatr. 2007 Aug;166(8):849-55
references: 17225950
references: Sci Transl Med. 2011 Jan 19;3(66):66cm1
references: 21248312
references: JAMA. 2006 Sep 13;296(10):1266-73
references: 16968851
references: Pediatrics. 2008 Mar;121(3):530-9
references: 18310202
references: N Engl J Med. 2002 Oct 31;347(18):1462-70
references: 12409558
references: Future Child. 2012 Spring;22(1):13-42
references: 22550684