VaticanAntonuccioJune2013

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  

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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unpublished)  using  the  newer  (SSRI  and  SNRI)  anQdepressants  with  depressed  children  were  posiQve    

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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  

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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  

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•  There  is  minimal  evidence  of  anQdepressant  efficacy  in  children  

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FDA  data  on  Serious  Suicide-­‐related  Events  in  SSRIs  &  SNRIs  

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TADS  Study  (2004)  

01020304050607080

%

N=439 adolescents with MDD

Acute Response on CGI

combinedfluoxetineCBTplacebo

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TADS  (2004)  

CDRS-R Scale

86

14

Placebo Response

"True" FluoxetineResponse

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TADS  Study  (2004)  

0

2

4

6

8

10

12

%

OR=2.19 (1.03-4.62)

Harm-related adverse events (including suicidal ideation)

fluoxetineno fluoxetine

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TADS  Study  (2004)  

0

2

4

6

8

10

12

14

16

18

%

Psychiatric Adverse Events (e.g.,irritability, mania, & fatigue)

FluoxetineCombinationPlaceboCBT

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TADS  Study  (2004)  

0

1

2

3

4

5

6

%

sed GI dia flu insom sinus vomit

Nonpsychiatric Adverse Events with OR>2

fluoxetineplacebo

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TADS  Follow-­‐up  (2007)  

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TADS  Follow-­‐up  (2007)  

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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  

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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”  

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Breakdown  by  drug  -­‐-­‐  FDA  view  (Turner  et  al.,  2008)  

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Breakdown  by  drug  -­‐-­‐    Journal  view  Turner  et  al.,  2008  

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AlternaQve  Labels  for  MedicaQons  We  Currently  Call  AnQdepressants  (Antonuccio  &  Healy,  2012)  

•  AnQ-­‐aphrodisiacs    •  AgitaQon  enhancers  •  Insomnia  inducers  •  Suicidality  inducers  •  Mania  sQmulators  •  Gas  busters  

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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  

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