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VaticanAntonuccioJune2013

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This is David Antonuccio’s presentation from the Vatican conference about children and psychotropics. The bottom line to all of our presentations was that given the evidence regarding minimal benefit …

This is David Antonuccio’s presentation from the Vatican conference about children and psychotropics. The bottom line to all of our presentations was that given the evidence regarding minimal benefit and substantial risk, psychosocial options should be first.

Published in: Health & Medicine, Technology

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  • 1. Psychotherapy  for  Depressed  Children:    No  Stronger  Medicine  By  David  Antonuccio,  Ph.D.  Professor  Emeritus  of  Psychiatry  and  Behavioral  Sciences,  University  of  Nevada  School  of  Medicine  6/14/13   Antonuccio   1  
  • 2. FDA  2004  Analysis  •  Only  3  out  of  16  controlled  studies  (published  and  unpublished)  using  the  newer  (SSRI  and  SNRI)  anQdepressants  with  depressed  children  were  posiQve    6/14/13   Antonuccio   2  
  • 3. Key  ArQcles  on  AnQdepressants  and  Children  •  Whittington et al. (2004), Lancet •  Juredeini et al. (2004), BMJ •  Garland (2004), CMAJ •  Whittington et al. (2005), Current Opinions in Psychiatry •  Hammad et al., (2006), Archives of General Psychiatry •  Dubicka et al. (2006), Br J Psychiatry •  Wohlfarth et al. (2006), Eur Psychopharm •  Bridge et al. (2007), JAMA •  Moreno et al. (2007), Acta Psychiatr Scanda •  Hetrick et al. (2007), Cochrane database •  Drews  et  al.,  (2011).  Journal  of  Mind-­‐Body  RegulaQon  6/14/13   Antonuccio   3  
  • 4. Risk/Benefit  Profiles  for  Popular  AnQdepressants  (WhiXngton  et  al.,  2004)  •  Unfavorable  for  paroxeQne  •  Unfavorable  for  sertraline  •  Unfavorable  for  citalopram  •  Unfavorable  for  venlafaxine  •  Favorable  for  FluoxeQne  6/14/13   Antonuccio   4  
  • 5. •  There  is  minimal  evidence  of  anQdepressant  efficacy  in  children  6/14/13   Antonuccio   5  
  • 6. FDA  data  on  Serious  Suicide-­‐related  Events  in  SSRIs  &  SNRIs  Antonuccio  6/14/13   6  
  • 7. TADS  Study  (2004)  01020304050607080%N=439 adolescents with MDDAcute Response on CGIcombinedfluoxetineCBTplaceboAntonuccio  6/14/13   7  
  • 8. TADS  (2004)  CDRS-R Scale8614Placebo Response"True" FluoxetineResponseAntonuccio  6/14/13   8  
  • 9. TADS  Study  (2004)  024681012%OR=2.19 (1.03-4.62)Harm-related adverse events(including suicidal ideation)fluoxetineno fluoxetineAntonuccio  6/14/13   9  
  • 10. TADS  Study  (2004)  024681012141618%Psychiatric Adverse Events (e.g.,irritability, mania, & fatigue)FluoxetineCombinationPlaceboCBTAntonuccio  6/14/13   10  
  • 11. TADS  Study  (2004)  0123456%sed GI dia flu insom sinus vomitNonpsychiatric Adverse Events with OR>2fluoxetineplaceboAntonuccio  6/14/13   11  
  • 12. TADS  Follow-­‐up  (2007)  Antonuccio  6/14/13   12  
  • 13. TADS  Follow-­‐up  (2007)  Antonuccio  6/14/13   13  
  • 14. Juredeini  et  al.  (2004)  •  CriQcally  reviewed  published  literature  on  anQdepressants  in  children  •  Found  inflated  benefits  and  minimized  harm  •  Half  clinician  measures  favored  study  drug  •  None  of  paQent  or  parent  measures  favored  study  drug  •  Effects  were  small  and  of  quesQonable  clinical  significance  •  Reliance  on  quesQonable  staQsQcal  pracQces  •  Possible  unblinding  due  to  side  effects  6/14/13   Antonuccio   14  
  • 15. Keller  et  al.  (2001)  in  Journal  of  the  American  Academy  of  Child  and  Adolescent  Psychiatry  •  Randomly  assigned  275  children  with  MD  to  paxil,  imipramine,  or  placebo  •  7  children  in  paxil  condiQon  had  to  be  hospitalized  compared  with  0  in  the  placebo  condiQon  •  The  drug  “was  generally  well  tolerated  in  this  adolescent  populaQon,  and  most  adverse  effects  were  not  serious”  6/14/13   Antonuccio   15  
  • 16. 6/14/13   Antonuccio   16  
  • 17. Breakdown  by  drug  -­‐-­‐  FDA  view  (Turner  et  al.,  2008)  Antonuccio  6/14/13   17  
  • 18. Breakdown  by  drug  -­‐-­‐    Journal  view  Turner  et  al.,  2008  Antonuccio  6/14/13   18  
  • 19. AlternaQve  Labels  for  MedicaQons  We  Currently  Call  AnQdepressants  (Antonuccio  &  Healy,  2012)  •  AnQ-­‐aphrodisiacs    •  AgitaQon  enhancers  •  Insomnia  inducers  •  Suicidality  inducers  •  Mania  sQmulators  •  Gas  busters  6/14/13   Antonuccio   19  
  • 20. The  End  • This  presentaQon  can  be  found  at  heartandsoulofchange.com  • Also  Check  out  Rxisk.org  for  independent  analysis  of  side  effect  data  for  all  prescripQon  drugs  6/14/13   Antonuccio   20