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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 Marc B. Stone, MD Senior Medical Reviewer Division of Neurology Products / Division of Psychiatry Products
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
Studies of Adults Grouping by Indication
Indication Groupings • Major Depressive Disorder (MDD) • Other Depressive Disorders • Other Psychiatric Disorders • Behavioral Indications • Other Indications
Studies of Adults Grouping by Drug Class
Studies of Adults Grouping by Age
Suicidal Behavior or Ideation by Age Psychiatric Indications
Suicidal Behavior or Ideation by Age Psychiatric Indications
Pediatric Studies • 24 Trials • 4487 subjects • Age range 6 – 18 years
Suicidal Behavior or IdeationAll Drugs – Psychiatric Indications
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
Adult and Pediatric StudiesSubjects <Age 25Suicidal Behavior or Ideation
Adult and Pediatric StudiesSubjects <Age 25Suicidal Behavior
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
Completed Suicides SSRI vs. Placebo Control in Adults * Excludes Fluoxetine and non-depression indications for Citalopram
Non-Fatal Self Harm SSRI vs. Placebo Control in Adults * Excludes non-depression indications for Citalopram
Suicidal Thoughts SSRI vs. Placebo Control in Adults * Excludes non-depression indications for Citalopram
Fergusson et al. • Trials reported in the public domain • Published papers • Cochrane registry • Cochrane methodology • Suicidality events not reviewed or subjected to standard criteria
Findings The observed relationship between antidepressant drug treatment and the incidence of reported suicidality events in clinical trials is strongly related to age