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These are Barry’s slides from the Rome Conference on Children and Psychotropics. The presentation conducts a risk/benefit analyses of the clinical trial research of three psychotropic medications used with youth: antidepressants, psychostimulants, and antipsychotics. This examination of the major studies fails to provide the proof of efficacy and safety so often cited in professional and lay press. A risk/benefit analysis suggests that psychosocial options be considered first, based on patient preferences. Check out interviews from the conference here:

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  1. 1. Barry Duncan, Psy.D. heartandsoulofchange.com561.239.3640 barrylduncan@comcast.netThe Appropriateness of Medicalisationas a Privileged Therapeutic ChoiceThe Evidence Indicates PsychosocialOptions Should Be First
  2. 2. Youth Prescription RatesIncreasing Globally In the US, spending for medsfor child behavior problemseclipsed any other drugcategory, including antibiotics While the US leads the worldin psychotropic prescriptionsto youth, global use ofstimulants has increased by274% and antipsychotics havedoubled across Europe
  3. 3. Study of poor childrenfound that 26% onantipsychotics; Poorchildren 4 times morelikely to be onantipsychotics57% of foster childrenare taking 3 or morepsychiatric drugs, 6times national averageApparently, children are vulnerable to psychotropics used asinterventions of control rather than therapy.
  4. 4. The QuestionsChildren and Psychiatric Drugs Are the skyrocketingrates of prescriptionjustified by clinical trialevidence? Only clinicaltrial literature addressed What does a riskbenefit analyses revealabout psychotropics andyouth?
  5. 5.  FDA study of 4400 youthrevealed a risk of suicidalityof 4% in SSRI patients, twicethat of placebo; a follow upanalysis of 22 RCTs reportedsimilar findings; Finally, theFDA meta-analyzed 372 RCTsand reported that suicide riskincreased as age under 25decreasedSSRIs: AntidepressantsThe Risks and the Black Box
  6. 6. SSRIs: AntidepressantsThe BenefitOf 15 published andunpublished clinicaltrials, only 3 showsuperiority to placeboon primary measures;none on patient orparent measures.Antidepressants carry at least double the chance for suicidalideation and behavior…Black box warning…Nicole
  7. 7. Risk/Benefit Analysis: TADS(Treatment of Adolescent Depression Study) Multicenter, randomized,effectiveness trialfunded by NIMH. N=432 Short term (12-weeks) &long-term (36-weeks) ofadols. diagnosed w/MDD 4 groups: Prozac,placebo, CBT, Prozac +CBT
  8. 8. CBT alone hadcomparable outcome at 30weeks while theantidepressant treatmentgroups had significantlymore psychiatric adverseevents;What about Suicide Risk?SSRIsTADS: The Benefit
  9. 9. Treatment N SREs % SAsPlacebo 103 3 3 0CBT 108 5 5 1Fluoxetine alone 109 16 15 6Combination 107 9 8 3Placebo switched to fluoxetine orcombination9 9 100 6CBT switched to fluoxetine orcombination3 2 67 2Total Non-SSRI 211 8 4 1Total SSRI 228 36 19 17Suicide Related Events (SREs) and SuicideAttempts (SAs) in TADS (Vitiello et al., 2009)
  10. 10. Stimulants: The Multimodal TreatmentStudy of Children w/ADHD (MTA) Large 14 mo comparison ofmanaged med v. BT v.combined v. TAU(medicated) 19 outcome measures All 4 groups improved Concluded that MMsuperior to BT & Combinedbrought no advantages
  11. 11. StimulantsMTA: The BenefitFoundadvantage tomed group on 3of 19 measuresAt 36 months,groups did notdiffer.
  12. 12. StimulantsMTA: The Risk—Adverse Events 64% of the childrenexperienced ADRs;11% were rated asmoderate, and 3% assevere. Follow-up reveals sig.growth reduction withno rebound
  13. 13. Antipsychotics: Treatment of Early OnsetSchiz. Spectrum Disorders (TEOSS) TEOSS compared two SGAs(Risperdal & Zyprexa) to aFGA (Moban). At the end of eight weeks,the “response” rate was50% for those treated withMoban, 46% for Risperdal,and 34% for Zyprexa; 41%didn‟t complete 8 weeks.Minimalimprovement onthe PANSScountedas “response”
  14. 14. AntipsychoticsTEOSS: The Risks—Suicide 1 suicide & 8 (8%) werehospitalized for suicidalityor worsening psychosis—atrisk excluded. Weight gain resulted insuspension of Zyprexa arm. Adverse events “frequent.”“May place many youth atrisk for diabetes andcardiovascular problems.”
  15. 15. AntipsychoticsTEOSS: Ultimate Risk and Benefit The 54 who “responded”during the initial 8 weeksentered into the 44-weekmaintenance study 40 of 54 dropped out for“adverse effects” or“inadequate response.” Only14 of 116 youth respondedand stayed on the med forone year—only 12%.
  16. 16. Psychotropic MedicationsThe Risks That Don‟t Make the AdsAntidepressant Risks: Mania—5times the rate of placebo; „Warning‟for suicidal behavior—at least twicethe rate of placebo; stunted growthStimulant Risks: „Warnings‟ forsuicide and cardiac risk; loss of 1 cmand 2.7 kg per yr; Mania, psychosis,cardiac sudden death; 64% reportadverse reactionsAntipsychotic Risks: Diabetes,obesity; EPS, tardive dyskinesia,neuroleptic malignant syndrome,suicide, akathisiaThere is no informed consentwith children. Parents andhelpers need to know
  17. 17. ConclusionsA Risk Benefit Analyses Does not support meds asa first intervention; shoulddiscuss risks and benefits Offer alternatives: Church,community, & counselingin concert w/values,culture, and preferences. Where there are nooptions, create them
  18. 18. Where Children Are ConcernedThe Stakes Are HigherDo not have a voice to sayno and depend on adultsto safeguard wellbeing;poor children have feweradults watching over themand are vulnerable todangerous drugs used forcontrol rather thantherapy. It’s up to us toensure their safety.
  19. 19. Now That You KnowThe Risk/Benefit Analyses I hope that tomorrowyou will recommendcaution of commercialinterests that have nomoral conscience, a keenattention to the evidence,ongoing study of thisissue that broadenspsychosocial options, anda follow up conference.Having heard this,you may choose tolook the other way,but you can neversay again that youdid not know.William Wilburforce,Address to the EnglishParliament regardingthe Slave Trade