{
 "note": "Added in the correction, after the results were known and in answer to review. The earlier analyses' estimates as their papers give them, and which of the trials here their data hold or could hold. The trials behind the re-analyses' estimates are matched by the study numbers the FDA's medical reviews list and the protocol numbers ClinicalTrials.gov gives; no list of the FDA's 2006 adult trials is public, so a comparison is counted as possibly among them by drug and date alone.",
 "estimates": {
  "stone_2009_behaviour_25_64": {
   "value": 1.03,
   "lo": 0.68,
   "hi": 1.58,
   "source": "doi:10.1136/bmj.b2880",
   "where": "Table 6, suicidal behaviour (preparation or worse), ages 25-64: 69 of 41,331 on drug and 34 of 22,126 on placebo, odds ratio 1.03 (0.68 to 1.58)."
  },
  "stone_2009_behaviour_25_and_over": {
   "value": 0.87,
   "lo": 0.58,
   "hi": 1.29,
   "source": "doi:10.1136/bmj.b2880",
   "where": "Table 6, suicidal behaviour, ages 25 and over: 70 of 45,263 on drug and 41 of 24,543 on placebo, odds ratio 0.87 (0.58 to 1.29). The abstract gives this estimate for ages 25 to 64, and the plan registered it as such (stone_2009_behaviour_25_64 in parameters.json)."
  },
  "stone_2009_suicidality_25_64": {
   "value": 0.79,
   "lo": 0.64,
   "hi": 0.98,
   "source": "doi:10.1136/bmj.b2880",
   "where": "Table 6, ideation or worse, ages 25-64: 238 of 41,331 on drug and 152 of 22,126 on placebo."
  },
  "hengartner_2019_attempts": {
   "value": 2.38,
   "lo": 1.63,
   "hi": 3.61,
   "source": "doi:10.1159/000501215",
   "where": "Suicide attempts, pooled from Table 1 of Khan et al. (2018)."
  },
  "kaminski_2020_attempts": {
   "value": 1.63,
   "lo": 1.09,
   "hi": 2.43,
   "source": "doi:10.1016/j.jad.2020.01.107",
   "where": "Suicide attempts, Mantel-Haenszel without continuity correction, from the same data."
  },
  "hammad_2006_pediatric_suicidality": {
   "value": 1.95,
   "lo": 1.28,
   "hi": 2.98,
   "source": "doi:10.1001/archpsyc.63.3.332",
   "where": "Suicidality, risk ratio across the pediatric trials."
  }
 },
 "datasets": {
  "stone_2009": {
   "source": "doi:10.1136/bmj.b2880",
   "what": "Completed double-blind placebo-controlled trials of antidepressants in adults, any indication, at least 20 participants per arm, that the sponsors of 12 marketed antidepressants submitted between September 2005 and September 2006, and the drugs studied in them, tested or as active controls. No list of the trials is public, so a comparison of one of these drugs completed by September 2006 is counted as possibly among them.",
   "molecules": [
    "amitriptyline",
    "bupropion",
    "citalopram",
    "clomipramine",
    "desipramine",
    "dosulepin",
    "duloxetine",
    "escitalopram",
    "fluoxetine",
    "fluvoxamine",
    "imipramine",
    "mianserin",
    "mirtazapine",
    "nefazodone",
    "paroxetine",
    "sertraline",
    "trazodone",
    "venlafaxine"
   ],
   "completed_by": "2006-09"
  },
  "khan_2018": {
   "source": "doi:10.1007/s00213-018-4856-1",
   "what": "The integrated safety summaries in the approval packets of 14 antidepressant programmes for adult major depressive disorder approved from 1991 to 2013 (sertraline 1991, paroxetine 1992, venlafaxine 1993 and its extended release 1997, nefazodone 1994, mirtazapine 1996, citalopram 1998, escitalopram 2002, duloxetine 2002, desvenlafaxine 2008, trazodone extended release 2010, vilazodone 2011, levomilnacipran 2013, vortioxetine 2013), which Hengartner and Plöderl (2019) and Kaminski and Bschor (2020) re-analysed. For vortioxetine Khan et al. used the short-term studies only. The FDA's medical reviews list the studies in the five newest programmes; no trial here of an older programme's drug was completed by the year of its approval packet.",
   "reviews": {
    "desvenlafaxine": {
     "review": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021992s000TOC.html",
     "studies": [
      "223",
      "304",
      "306",
      "308",
      "309",
      "317",
      "320",
      "302",
      "303",
      "307",
      "318"
     ]
    },
    "trazodone": {
     "review": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411s000MedR.pdf",
     "studies": [
      "04ACL3-001"
     ]
    },
    "vilazodone": {
     "review": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000MedR.pdf",
     "studies": [
      "GPP-007-CLN-CP2-2001-244",
      "GPP-007-CLN-CP2-2001-245",
      "GPP-007-CLN-CP2-2001-246",
      "GPP-007-CLN-CP2-2001-247",
      "GPP-007-CLN-CP2-2001-248",
      "GNSC-04-DP-02",
      "CLDA-07-DP-02"
     ]
    },
    "levomilnacipran": {
     "review": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000MedR.pdf",
     "studies": [
      "LVM-MD-01",
      "LVM-MD-02",
      "LVM-MD-03",
      "LVM-MD-04",
      "LVM-MD-05",
      "LVM-MD-10",
      "F02695 LP 2 02"
     ]
    },
    "vortioxetine": {
     "review": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000MedR.pdf",
     "studies": [
      "303",
      "304",
      "305",
      "315",
      "316",
      "317",
      "11492A",
      "11984A",
      "12541A",
      "13267A"
     ],
     "pool": "MDD Short-Term Pool"
    }
   },
   "trials": [
    {
     "nct": "NCT00672958",
     "protocol": "LuAA21004_303",
     "study": "303",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT00672620",
     "protocol": "LuAA21004_304",
     "study": "304",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT00735709",
     "protocol": "LuAA21004_305",
     "study": "305",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT01153009",
     "protocol": "LuAA21004_315",
     "study": "315",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT01163266",
     "protocol": "LuAA21004_316",
     "study": "316",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT01179516",
     "protocol": "LuAA21004_317",
     "study": "317",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT00839423",
     "protocol": "11492A",
     "study": "11492A",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT00635219",
     "protocol": "11984A",
     "study": "11984A",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT00811252",
     "protocol": "12541A",
     "study": "12541A",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT01140906",
     "protocol": "13267A",
     "study": "13267A",
     "programme": "vortioxetine"
    },
    {
     "nct": "NCT00969709",
     "protocol": "LVM-MD-01",
     "study": "LVM-MD-01",
     "programme": "levomilnacipran"
    },
    {
     "nct": "NCT00969150",
     "protocol": "LVM-MD-02",
     "study": "LVM-MD-02",
     "programme": "levomilnacipran"
    },
    {
     "nct": "NCT01034462",
     "protocol": "LVM-MD-03",
     "study": "LVM-MD-03",
     "programme": "levomilnacipran"
    },
    {
     "nct": "NCT01377194",
     "protocol": "LVM-MD-10",
     "study": "LVM-MD-10",
     "programme": "levomilnacipran"
    },
    {
     "nct": "NCT00683592",
     "protocol": "CLDA-07-DP-02",
     "study": "CLDA-07-DP-02",
     "programme": "vilazodone"
    },
    {
     "nct": "NCT00775203",
     "protocol": "04ACL3-001",
     "study": "04ACL3-001",
     "programme": "trazodone"
    }
   ]
  },
  "hammad_2006": {
   "source": "doi:10.1001/archpsyc.63.3.332",
   "what": "24 pediatric trials, submitted to the FDA by May 2004; the FDA's review lists them. Every pediatric trial here was completed later.",
   "completed_by": "2004-05"
  }
 }
}