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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

Antidepressant Drugs and Suicidality

Marc B. Stone, MD

Senior Medical Reviewer

Division of Neurology Products / Division of Psychiatry Products

analytical approach
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 adults5

Studies of Adults

Grouping by Indication

indication groupings
Indication Groupings
  • Major Depressive Disorder (MDD)
  • Other Depressive Disorders
  • Other Psychiatric Disorders
  • Behavioral Indications
  • Other Indications
studies of adults11

Studies of Adults

Grouping by Drug Class

studies of adults15

Studies of Adults

Grouping by Age

pediatric studies
Pediatric Studies
  • 24 Trials
  • 4487 subjects
  • Age range 6 – 18 years
slide30

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

gunnell et al
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
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
Non-Fatal Self Harm SSRI vs. Placebo Control in Adults

* Excludes non-depression indications for Citalopram

suicidal thoughts ssri vs placebo control in adults
Suicidal Thoughts SSRI vs. Placebo Control in Adults

* Excludes non-depression indications for Citalopram

fergusson et al
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
Findings

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

findings51
Findings

When suicidal behavior and ideation are considered together, the risk associated with drug treatment relative to placebo is

  • Elevated in subjects under age 25
  • Reduced in subjects ages 25 – 64
  • Further reduced in subjects age 65 and older
findings52
Findings

When suicidal behavior alone is considered, the risk associated with drug treatment relative to placebo is

  • Elevated in subjects under age 25
  • Neutral in subjects ages 25 – 64
  • Reduced in subjects age 65 and older
findings53
Findings

The observed relationship between suicidality, age and antidepressant treatment appears not only in major depressive disorder but in all subjects with psychiatric diagnoses.

interpretation
Interpretation
  • The observations are most consistent with two general effects:
    • One promoting suicidality
    • One preventing it
    • In older subjects the preventative effect tends to predominate while in younger subjects the opposite is true
    • A simpler explanation that denies a preventative effect and assumes only a promoting effect does not explain the protective effect seen in older subjects
reporting effects
Reporting Effects

Could antidepressant treatment simply cause more events to be reported?

  • Could treatment allow subjects, particularly younger subjects, to simply become more articulate and open about their thoughts and actions?
reporting effects56
Reporting Effects

However

  • Drug effect appears to be at least as great on suicidal behavior as on suicidal thoughts
  • Suicidal behavior is potentially directly observable
reporting effects57
Reporting Effects

For a reporting effect to credibly explain the results

    • Drug treatment must have a substantially greater effect on the reporting of suicidal behavior than the reporting of suicidal thoughts or
    • Almost all suicidal behavior was self-reported rather than observed by others
  • Reporting effects must be strongly age related
for future investigation
For Future Investigation

Differences between drugs and drug classes need confirmation and, if confirmed, explanation.