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 {
  "local_id": "C1",
  "type": "empirical",
  "core": false,
  "statement": "Of the 932 interventional studies naming an antidepressant with results posted on ClinicalTrials.gov on 2026-10-13, 393 randomized trials compare an antidepressant with placebo in 413 comparisons with 99,730 participants at risk in their adverse-event tables. In the 306 adult trials that randomized participants from the start (71,643 participants), nausea is more frequent on antidepressants in the 207 comparisons whose non-serious tables list it (57,580 participants; Mantel-Haenszel risk ratio 2.08, 95% CI 1.98 to 2.18), as these drugs' known side effects predict.",
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    "result": "S.trials.found",
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   {
    "result": "S.trials.eligible",
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    "result": "S.trials.comparisons",
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    "result": "S.trials.participants",
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    "result": "S.trials.adult_trials",
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    "result": "S.trials.adult_participants",
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    "result": "S.checks.K1.all.comparisons",
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    "result": "S.checks.K1.all.participants",
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    "result": "S.checks.K1.all.rr",
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    "result": "S.checks.K1.all.lo",
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    "result": "S.checks.K1.all.hi",
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    "result": "S.checks.K1.as_expected",
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  "falsified_if": "A rerun finds different numbers of trials, comparisons or participants, or a nausea risk ratio whose interval includes 1.",
  "confidence": 0.95
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 {
  "local_id": "C2",
  "type": "empirical",
  "core": true,
  "statement": "In those adult trials, the posted tables bound the participants with serious suicidal behaviour (completed suicide, suicide attempt, intentional self-harm or intentional overdose) at 43 to 46 of 40,564 on antidepressants and 16 to 19 of 31,079 on placebo, and those with any serious suicidality at 71 to 81 against 36 to 43, because a participant listed under two of an outcome's terms may be one person or two. Across every count the tables allow, the Mantel-Haenszel risk ratio is 1.76 to 2.20 for serious suicidal behaviour (p 0.0097 to 0.0502) and 1.29 to 1.73 for any serious suicidality (p 0.0078 to 0.20). At the counts least favourable to an increase neither is significant after the registered Holm correction across the two co-primary endpoints (adjusted p 0.10 and 0.20); at the most favourable both are (0.016 and 0.016).",
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    "result": "S.corrected.bounds.P2.p_min",
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    "result": "S.corrected.bounds.P1.holm_at_p_max",
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    "result": "S.corrected.bounds.P2.holm_at_p_max",
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    "result": "S.corrected.bounds.P1.holm_at_p_min",
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  "depends_on": [
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  "falsified_if": "A rerun gives different bounds, risk ratios or p-values, or a Holm-adjusted p below 0.05 for either endpoint at the counts least favourable to an increase.",
  "confidence": 0.9
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 {
  "local_id": "C3",
  "type": "empirical",
  "core": true,
  "statement": "Public reports of the trials (their publications, regulators' reviews and the sponsors' documents) settle how many participants share terms in 11 of the 17 adverse-event groups the tables leave open and narrow it in 3 more. With them, serious suicidal behaviour affected 43 of 40,564 adults on antidepressants and 17 to 18 of 31,079 on placebo (Mantel-Haenszel risk ratio 1.86 to 1.96; p 0.025 to 0.036), and any serious suicidality 72 to 77 against 40 to 41 (1.38 to 1.51; p 0.041 to 0.12). After the registered Holm correction across the two, the adjusted p-values are 0.071 and 0.12 at the counts least favourable to an increase and 0.0496 for both at the most favourable.",
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    "result": "S.corrected.resolution.groups_settled",
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    "result": "S.corrected.resolution.groups",
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    "result": "S.corrected.resolved.P1.drug_least",
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    "result": "S.corrected.resolved.P1.drug_at_risk",
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    "result": "S.corrected.resolved.P1.placebo_least",
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    "result": "S.corrected.resolved.P1.rr_min",
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    "result": "S.corrected.resolved.P1.rr_max",
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   {
    "result": "S.corrected.resolved.P1.p_min",
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   {
    "result": "S.corrected.resolved.P1.p_max",
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   {
    "result": "S.corrected.resolved.P2.drug_least",
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   {
    "result": "S.corrected.resolved.P2.drug_most",
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    "result": "S.corrected.resolved.P2.placebo_least",
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   {
    "result": "S.corrected.resolved.P2.placebo_most",
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    "result": "S.corrected.resolved.P2.rr_min",
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    "result": "S.corrected.resolved.P2.rr_max",
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    "result": "S.corrected.resolved.P2.p_min",
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    "result": "S.corrected.resolved.P2.p_max",
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    "result": "S.corrected.resolved.P1.holm_at_p_max",
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   {
    "result": "S.corrected.resolved.P2.holm_at_p_max",
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   {
    "result": "S.corrected.resolved.P1.holm_at_p_min",
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    "result": "S.corrected.resolved.P2.holm_at_p_min",
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    "result": "S.corrected.resolution.groups_unresolved",
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  "depends_on": [
   "C2"
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  "falsified_if": "A rerun gives different counts or estimates, or a report cited in data/resolved.json is shown not to say what it records, or a Holm-adjusted p below 0.05 for either endpoint at the counts least favourable to an increase.",
  "confidence": 0.85
 },
 {
  "local_id": "C4",
  "type": "empirical",
  "core": false,
  "statement": "The registered random-effects estimates for those outcomes (1.22 and 1.10) are smaller than the Mantel-Haenszel estimates because that method adds 0.5 to every cell of the comparisons with no events in one arm (37 of the 43 with serious suicidal behaviour and 46 of the 61 with any serious suicidality) and weights comparisons by their inverse variance, not because the comparisons differ: it estimates the variance between them at 0.00 for the first and 0.00 for the second, and a random-effects model conditional on each comparison's events, which needs no correction, gives 1.73 to 2.15 for serious suicidal behaviour and 1.31 to 1.72 for any serious suicidality between the counts least and most favourable to an increase. Suicide attempt, the most frequent term of serious suicidal behaviour, which no group lists twice, affected 27 participants on antidepressants and 13 on placebo (risk ratio 1.59, 95% CI 0.79 to 3.20).",
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   {
    "result": "S.primary.P2.random_effects.rr",
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   {
    "result": "S.corrected.estimators.P1.with_a_zero_cell",
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   {
    "result": "S.corrected.estimators.P1.comparisons_with_events",
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   {
    "result": "S.corrected.estimators.P2.with_a_zero_cell",
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   {
    "result": "S.corrected.estimators.P2.comparisons_with_events",
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   {
    "result": "S.corrected.estimators.P1.dl.tau2",
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    "result": "S.corrected.estimators.P2.dl.tau2",
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    "result": "S.corrected.estimators.P1.lowest_random.rr",
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   {
    "result": "S.corrected.estimators.P1.highest_random.rr",
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   {
    "result": "S.corrected.estimators.P2.lowest_random.rr",
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   {
    "result": "S.corrected.estimators.P2.highest_random.rr",
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   {
    "result": "S.corrected.single_term.P1.drug_least",
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   {
    "result": "S.corrected.single_term.P1.placebo_least",
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   {
    "result": "S.corrected.single_term.P1.rr_min",
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   {
    "result": "S.corrected.single_term.P1.lo_min",
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   {
    "result": "S.corrected.single_term.P1.hi_max",
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   {
    "result": "S.corrected.single_term.P1.term",
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    "result": "S.corrected.single_term.P1.ambiguous_arms",
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  ],
  "depends_on": [
   "C2"
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  "falsified_if": "A rerun gives a between-comparison variance above zero in the registered random-effects model, different estimates from the model without correction, or different counts or estimates for suicide attempt.",
  "confidence": 0.85
 },
 {
  "local_id": "C5",
  "type": "empirical",
  "core": true,
  "statement": "The FDA's medical reviews list 16 of those adult trials (8,487 participants) among the studies of the approval programmes whose data the re-analyses of FDA data used, and in them serious suicidal behaviour affected 7 to 9 participants on antidepressants and 1 on placebo. In the 304 comparisons that neither those data nor, by drug and date, the FDA's 2006 adult data could hold (62,652 participants), it affected 36 to 37 against 15 to 18 (risk ratio 1.64 to 1.98; p 0.030 to 0.097), and with the trials' public reports 36 against 16 to 17 (1.73 to 1.83; p 0.0497 to 0.070).",
  "evidence": [
   {
    "result": "S.corrected.independence.P1.in_reanalyses.trials",
    "produced_by": "code/summarize.py"
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   {
    "result": "S.corrected.independence.P1.in_reanalyses.participants",
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   {
    "result": "S.corrected.independence.P1.in_reanalyses.drug_least",
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   {
    "result": "S.corrected.independence.P1.in_reanalyses.drug_most",
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   {
    "result": "S.corrected.independence.P1.in_reanalyses.placebo_least",
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    "result": "S.corrected.independence.P1.neither.comparisons",
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    "result": "S.corrected.independence.P1.neither.participants",
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    "result": "S.corrected.independence.P1.neither.drug_least",
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    "result": "S.corrected.independence.P1.neither.drug_most",
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    "result": "S.corrected.independence.P1.neither.placebo_least",
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    "result": "S.corrected.independence.P1.neither.placebo_most",
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    "result": "S.corrected.independence.P1.neither.rr_min",
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    "result": "S.corrected.independence.P1.neither.rr_max",
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    "result": "S.corrected.independence.P1.neither.p_min",
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    "result": "S.corrected.independence.P1.neither.p_max",
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    "result": "S.corrected.independence.P1.neither.resolved.drug_least",
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    "result": "S.corrected.independence.P1.neither.resolved.placebo_least",
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   {
    "result": "S.corrected.independence.P1.neither.resolved.placebo_most",
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    "result": "S.corrected.independence.P1.neither.resolved.rr_max",
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    "result": "S.corrected.independence.P1.neither.resolved.p_min",
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  "falsified_if": "A rerun gives different counts or estimates, or a trial matched here is shown not to be the study the FDA's review lists.",
  "confidence": 0.85
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 {
  "local_id": "C6",
  "type": "empirical",
  "core": false,
  "statement": "In 30 pediatric trials randomized from the start (7,094 participants), all completed in 2006 or later, after the FDA's 2004 pediatric analysis, any serious suicidality affected 34 to 37 of 4,547 participants on antidepressants and 7 to 8 of 2,547 on placebo (risk ratio 2.15 to 2.70; p 0.018 to 0.051; Benjamini-Hochberg q 0.044 to 0.13 across the secondary analyses), intervals that contain the FDA's pediatric estimate of 1.95 at every count, while serious suicidal behaviour alone was 13 to 14 against 4 to 5 (1.08 to 1.48). The trials' public reports settle every pediatric group the tables leave open: with them, any serious suicidality affected 35 against 8 (risk ratio 2.20, 95% CI 1.02 to 4.75; p 0.044; q 0.11) and serious suicidal behaviour 13 against 5 (1.08).",
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    "result": "S.corrected.bounds.A19.q_at_p_max",
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    "result": "S.earlier.hammad_2006_pediatric_suicidality.value",
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    "result": "S.corrected.resolved.A19.p_min",
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    "result": "S.corrected.resolved.A19.q_at_p_max",
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    "result": "S.corrected.resolved.A18.drug_least",
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   {
    "result": "S.corrected.resolved.A18.placebo_least",
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   {
    "result": "S.corrected.resolved.A18.rr_min",
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   {
    "result": "S.corrected.independence.pediatric.completed_after_fda_2004",
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   {
    "result": "S.corrected.independence.pediatric.comparisons",
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   {
    "result": "S.corrected.against.A19.hammad_2006_pediatric_suicidality",
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  "depends_on": [
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  "falsified_if": "A rerun gives different counts or estimates, or a pediatric suicidality interval that excludes 1.95 at some count.",
  "confidence": 0.8
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 {
  "local_id": "C7",
  "type": "empirical",
  "core": false,
  "statement": "In 131 adult trials of depressive disorders randomized from the start, serious suicidal behaviour affected 34 to 37 of 21,105 participants on antidepressants and 11 to 12 of 13,240 on placebo (risk ratio 2.03 to 2.37; p 0.017 to 0.046; q 0.044 to 0.13), and with the trials' public reports 34 against 11 (2.20; p 0.031; q 0.11), while across all adult trials serious suicidal ideation alone was 36 against 23 to 24 (1.18 to 1.23) and completed suicide 5 against 2, too few to test.",
  "evidence": [
   {
    "result": "S.trials.adult_depressive_trials",
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   {
    "result": "S.corrected.bounds.A6.drug_least",
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   {
    "result": "S.corrected.bounds.A6.drug_most",
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   {
    "result": "S.corrected.bounds.A6.drug_at_risk",
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   {
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   {
    "result": "S.corrected.bounds.A6.placebo_most",
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   {
    "result": "S.corrected.bounds.A6.placebo_at_risk",
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   {
    "result": "S.corrected.bounds.A6.rr_min",
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   {
    "result": "S.corrected.bounds.A6.rr_max",
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   {
    "result": "S.corrected.bounds.A6.p_min",
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   {
    "result": "S.corrected.bounds.A6.p_max",
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   {
    "result": "S.corrected.bounds.A6.q_at_p_min",
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   {
    "result": "S.corrected.bounds.A6.q_at_p_max",
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   {
    "result": "S.corrected.resolved.A6.drug_least",
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   {
    "result": "S.corrected.resolved.A6.placebo_least",
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   {
    "result": "S.corrected.resolved.A6.rr_min",
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   {
    "result": "S.corrected.resolved.A6.p_min",
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   {
    "result": "S.corrected.resolved.A6.q_at_p_max",
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   {
    "result": "S.corrected.bounds.A2.drug_least",
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   {
    "result": "S.corrected.bounds.A2.placebo_least",
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   {
    "result": "S.corrected.bounds.A2.placebo_most",
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   {
    "result": "S.corrected.bounds.A2.rr_min",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.corrected.bounds.A2.rr_max",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.corrected.bounds.A4.drug_least",
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   },
   {
    "result": "S.corrected.bounds.A4.placebo_least",
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   {
    "result": "S.corrected.bounds.A2.drug_most",
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   {
    "result": "S.corrected.bounds.A4.testable",
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  "depends_on": [
   "C1"
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  "falsified_if": "A rerun gives different counts or estimates, or a depressive-disorder p-value of 0.05 or more at some count.",
  "confidence": 0.8
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 {
  "local_id": "C8",
  "type": "empirical",
  "core": false,
  "statement": "Across the trials randomized from the start, the trial-level odds ratio shows no significant trend with the trials' mean age (9.3 to 60.8 years) at any count the tables allow: 0.8% to 2.3% per year for serious suicidal behaviour (51 comparisons with events; p 0.21 or more) and −1.8% to −0.6% per year for any serious suicidality (73 comparisons; p 0.12 or more), and every comparison with events takes its age from a posted mean.",
  "evidence": [
   {
    "result": "S.age.G1.age_min",
    "produced_by": "code/summarize.py"
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   {
    "result": "S.age.G1.age_max",
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   {
    "result": "S.corrected.age.G1.pct_min",
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   {
    "result": "S.corrected.age.G1.pct_max",
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   {
    "result": "S.corrected.age.G1.comparisons_with_events",
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   },
   {
    "result": "S.corrected.age.G1.p_min",
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   {
    "result": "S.corrected.age.G2.pct_min",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.corrected.age.G2.pct_max",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.corrected.age.G2.comparisons_with_events",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.corrected.age.G2.p_min",
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   {
    "result": "S.corrected.age.G1.median_age_comparisons",
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   {
    "result": "S.corrected.age.G2.median_age_comparisons",
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  ],
  "depends_on": [
   "C1"
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  "falsified_if": "A rerun gives a significant trend at some count, different slopes, or a comparison with events whose age is a posted median.",
  "confidence": 0.75
 },
 {
  "local_id": "C9",
  "type": "empirical",
  "core": false,
  "statement": "In the same adult trials, any serious adverse event, which the tables count once per participant, affected 913 of 40,564 participants on antidepressants and 743 of 31,079 on placebo (risk ratio 1.09, 95% CI 0.997 to 1.19; p 0.057), and death from any cause, in the 121 comparisons that reported it for every group (11,053 and 9,690 participants), 159 against 136 (1.17, 0.98 to 1.39).",
  "evidence": [
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    "result": "S.checks.K3.all.drug_affected",
    "produced_by": "code/summarize.py"
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   {
    "result": "S.checks.K3.all.drug_at_risk",
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   {
    "result": "S.checks.K3.all.placebo_affected",
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   {
    "result": "S.checks.K3.all.placebo_at_risk",
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   {
    "result": "S.checks.K3.all.rr",
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   {
    "result": "S.checks.K3.all.lo",
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   {
    "result": "S.checks.K3.all.hi",
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   {
    "result": "S.checks.K3.p",
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   {
    "result": "S.checks.K2.all.comparisons",
    "produced_by": "code/summarize.py"
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   {
    "result": "S.checks.K2.all.drug_at_risk",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.checks.K2.all.placebo_at_risk",
    "produced_by": "code/summarize.py"
   },
   {
    "result": "S.checks.K2.all.drug_affected",
    "produced_by": "code/summarize.py"
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   {
    "result": "S.checks.K2.all.placebo_affected",
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   {
    "result": "S.checks.K2.all.rr",
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   {
    "result": "S.checks.K2.all.lo",
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   {
    "result": "S.checks.K2.all.hi",
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  ],
  "depends_on": [
   "C1"
  ],
  "falsified_if": "A rerun gives different counts or estimates.",
  "confidence": 0.9
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]