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Antidepressant Drugs and Suicidality

Antidepressant Drugs and Suicidality. Marc B. Stone, MD Senior Medical Reviewer Division of Neurology Products / Division of Psychiatry Products. Analytical Approach. Include antidepressant active control arms Increases power

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Antidepressant Drugs and Suicidality

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  1. Antidepressant Drugs and Suicidality Marc B. Stone, MD Senior Medical Reviewer Division of Neurology Products / Division of Psychiatry Products

  2. Analytical Approach • Include antidepressant active control arms • Increases power • Allows consideration of tricyclics and other older antidepressants • Estimate odds ratios using conditional (fixed effects) logistic regression

  3. Studies of Adults

  4. All Indications All Subjects (including active controls)

  5. Studies of Adults Grouping by Indication

  6. Indication Groupings • Major Depressive Disorder (MDD) • Other Depressive Disorders • Other Psychiatric Disorders • Behavioral Indications • Other Indications

  7. Number of Suicidality Events

  8. Incidence of Suicidality Events

  9. Psychiatric Indications Only

  10. Studies of Adults Grouping by Drug Class

  11. Drug Class

  12. Studies of Adults Grouping by Age

  13. Suicidal Behavior or Ideation by Age Psychiatric Indications

  14. Suicidal Behavior or Ideation by Age Psychiatric Indications

  15. Suicidal Behavior by Age Psychiatric Indications

  16. Suicidal Behavior by Age Psychiatric Indications

  17. Comparison with Pediatric Studies

  18. Pediatric Studies • 24 Trials • 4487 subjects • Age range 6 – 18 years

  19. Pediatric Studies

  20. Suicidal Behavior or IdeationAll Drugs – Psychiatric Indications

  21. Suicidal BehaviorAll Drugs – Psychiatric Indications

  22. Suicidal Behavior or IdeationSSRI in MDD

  23. Suicidal Behavior or Ideation Pediatric and Adult Studies 3 Age <25 2 Odds Ratio 1 Age 25-64 Age 65+ 0 0 20 40 60 80 100 age

  24. Adult and Pediatric StudiesSubjects <Age 25Suicidal Behavior or Ideation

  25. Adult and Pediatric StudiesSubjects <Age 25Suicidal Behavior

  26. Comparison with Other Meta-Analyses

  27. Gunnell et al. • Summary data by drug, not trial, provided by sponsors to the MHRA • 6 SSRI drugs • 477 trials • 52,503 subjects • Suicidality events not reviewed or subjected to standard criteria

  28. Completed Suicides SSRI vs. Placebo Control in Adults * Excludes Fluoxetine and non-depression indications for Citalopram

  29. Completed Suicides SSRI vs. Placebo Control in Adults

  30. Non-Fatal Self Harm SSRI vs. Placebo Control in Adults * Excludes non-depression indications for Citalopram

  31. Non-Fatal Self Harm SSRI vs. Placebo Control in Adults

  32. Suicidal Thoughts SSRI vs. Placebo Control in Adults * Excludes non-depression indications for Citalopram

  33. Suicidal Thoughts in Placebo Controlled Trials in Adults

  34. Fergusson et al. • Trials reported in the public domain • Published papers • Cochrane registry • Cochrane methodology • Suicidality events not reviewed or subjected to standard criteria

  35. Suicide Attempts Controlled Trials of SSRIs in Adults

  36. Discussion

  37. Findings The observed relationship between antidepressant drug treatment and the incidence of reported suicidality events in clinical trials is strongly related to age

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