Erratum to: Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis. [BMC Psychiatry. (2017), 17:(58)]. doi: 10.1186/s12888-016-1173-2;Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

BMC Psychiatry

Volumn 17, Issue 1, 2017, Pages

  Jakobsen, Janus Christian ^a,b   Katakam, Kiran Kumar ^a   Schou, Anne ^a   Hellmuth, Signe Gade ^a   Stallknecht, Sandra Elkjær ^a   Leth Møller, Katja ^a   Iversen, Maria ^a   Banke, Marianne Bjørnø ^a   Petersen, Iggiannguaq Juhl ^a   Klingenberg, Sarah Louise ^a   Krogh, Jesper ^c   Ebert, Sebastian Elgaard ^a   Timm, Anne ^a   Lindschou, Jane ^a   Gluud, Christian ^a  

^a Rigshospitalet   (Denmark)

^b HOLBÆK HOSPITAL   (Denmark)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Depression; SSRI; Systematic review

Indexed keywords

CITALOPRAM; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; PAROXETINE; PLACEBO; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; ANTIDEPRESSANT AGENT;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ABSCESS; ACNE; ADVERSE OUTCOME; ALLERGIC REACTION; AMNESIA; ANGINA PECTORIS; ANOREXIA; ANXIETY DISORDER; AORTA ANEURYSM; APPENDICITIS; ARTICLE; ASTHENIA; ASTHMA; ATRIAL FIBRILLATION; BACKACHE; BECK DEPRESSION INVENTORY; BLURRED VISION; BREAST CANCER; BRONCHITIS; CARDIOVASCULAR DISEASE; CELLULITIS; CEREBROVASCULAR ACCIDENT; CEREBROVASCULAR DISEASE; CHOLELITHIASIS; CONFUSION; CONGESTIVE HEART FAILURE; CONSTIPATION; COUGHING; DATA BASE; DECREASED APPETITE; DEHYDRATION; DEPRESSION; DIARRHEA; DIZZINESS; DROWNING; DROWSINESS; DRUG FATALITY; DRUG OVERDOSE; DRUG SAFETY; DYSPEPSIA; DYSURIA; ECTOPIC PREGNANCY; EJACULATION DISORDER; EPISTAXIS; ERUCTATION; FAINTNESS; FATIGUE; FLATULENCE; FLU LIKE SYNDROME; FOLLOW UP; GALLBLADDER DISEASE; GASTRITIS; GASTROENTERITIS; GASTROINTESTINAL DISEASE; GYNECOLOGIC DISEASE; HAMILTON DEPRESSION RATING SCALE; HEADACHE; HEART ARRHYTHMIA; HEART DEATH; HEART INFARCTION; HEART PALPITATION; HEMATOTHORAX; HUMAN; HYPERTENSION; IMPOTENCE; INCREASED APPETITE; INFECTION; INJURY; INSOMNIA; LABYRINTHITIS; LIBIDO DISORDER; MAJOR DEPRESSION; MALAISE; META ANALYSIS; MIGRAINE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MOUTH ABSCESS; MYALGIA; NAUSEA; NECK ABSCESS; NEPHROLITHIASIS; OBSTRUCTIVE AIRWAY DISEASE; ORTHOSTATIC HYPOTENSION; PARESTHESIA; PLEURA DISEASE; PNEUMONIA; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RECTUM DISEASE; REMISSION; RESPIRATORY TRACT DISEASE; RESTLESSNESS; RHINITIS; SEXUAL DYSFUNCTION; SIDE EFFECT; SINUSITIS; SLEEP DISORDER; SOMNOLENCE; STOMACH DISEASE; SUICIDAL IDEATION; SUICIDE; SUICIDE ATTEMPT; SYSTEMATIC REVIEW; TACHYCARDIA; TASTE DISORDER; THORAX PAIN; THOUGHT DISORDER; TINNITUS; TREATMENT OUTCOME; TREMOR; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY DYSFUNCTION; UTERUS MYOMA; VERTIGO; VIRUS MENINGITIS; VOMITING; XEROSTOMIA; ADULT; DEPRESSIVE DISORDER;

ADULT; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; DEPRESSIVE DISORDER; HUMANS; PLACEBOS; QUALITY OF LIFE; SEROTONIN UPTAKE INHIBITORS; SUICIDAL IDEATION;

EID: 85012101620     PISSN: None     EISSN: 1471244X     Source Type: Journal    
DOI: 10.1186/s12888-017-1311-5     Document Type: Erratum

References (208)

1. Gualano MR, Bert F, Mannocci A, La Torre G, Zeppegno P, Siliquini R. Consumption of antidepressants in Italy: recent trends and their significance for public health. Psychiatr Serv. 2014;65(10):1226-31.
2. Wise J. GPs in England prescribed 2.7 million extra antidepressants during 2012 recession. BMJ. 2014;348:g3607.
3. Gibbons RD, Hur K, Brown CH, Davis JM, Mann JJ. Benefits from antidepressants: synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine. Arch Gen Psychiatry. 2012;69(6):572-9.
4. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303(1):47-53.
5. Khan A, Leventhal RM, Khan SR, Brown WA. Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol. 2002;22(1):40-5.
6. Undurraga J, Baldessarini RJ. Randomized, placebo-controlled trials of antidepressants for acute major depression: thirty-year meta-analytic review. Neuropsychopharmacol. 2012;37(4):851-64.
7. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-60.
8. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5(2):e45.
9. Arroll B, Elley CR, Fishman T, Goodyear-Smith FA, Kenealy T, Blashki G, Kerse N, MacGillivray S. Antidepressants versus placebo for depression in primary care. Cochrane Database of Syst Rev. 2009.
10. Wilson K, Mottram PG, Sivananthan A, Nightingale A. Antidepressants versus placebo for the depressed elderly. Cochrane Database Syst Rev. 2001.
11. Englev E, Petersen KP. ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives. Dan Med J. 2003;165(16):1659-62.
12. Jakobsen JC, Gluud C, Winkel P, Lange T, Wetterslev J. The thresholds for statistical and clinical significance - a five-step procedure for evaluation of intervention effects in randomised clinical trials. BMC Med Res Methodol. 2014;14:34.
13. Jakobsen JC, Wetterslev J, Winkel P, Lange T, Gluud C. Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods. BMC Med Res Methodol. 2014;14(1):120.
14. Jakobsen JC, Lindschou J, Hellmuth S, Schou A, Krogh J, Gluud C. The effects of selective serotonin reuptake inhibitors versus no intervention, placebo, or 'active' placebo in patients with major depressive disorder. A systematic review of randomised clinical trials with meta-analyses and trial sequential analyses. PROSPERO 2013:CRD42013004420 Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004420.
15. Moncrieff J, Wessely S, Hardy R. Active placebos versus antidepressants for depression. Coch Database Syst Rev. 2004;1:CD003012.
16. Higgins JPT, Green S. The Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration 2011, Available from http://www.cochrane-handbook.org/.
17. Jakobsen JC, Lindschou J, Hellmuth S, Schou A, Krogh J, Gluud C. The effects of selective serotonin reuptake inhibitors versus no intervention, placebo, or 'active' placebo in patients with major depressive disorder. A systematic review of randomised clinical trials with meta-analyses and trial sequential analyses. PROSPERO 2013:CRD42013004420 Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004420 2013.
18. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23(3):56-61.
19. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382-9.
20. Beck A, Steer RA, Brown GK. Beck depression inventory-second edition: manual. San Antonio: Psychological Corporation. 1996;4:561-71.
21. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, Norris S, Falck-Ytter Y, Glasziou P, DeBeer H, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383-94.
22. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-88.
23. The Nordic Cochrane Centre (The Cochrane Collaboration): Review Manager (RevMan) [Computer program]. Version 5.3. In.; 2008.
24. Brok J, Thorlund K, Gluud C, Wetterslev J. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analysis. J Clin Epidemiol. 2008;61:763-9.
25. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol. 2008;61(1):64-75.
26. Thorlund K, Devereaux PJ, Wetterslev J, Guyatt G, Ioannidis JP, Thabane L, Gluud LL, Als-Nielsen B, Gluud C. Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses? Int J Epidemiol. 2009;38(1):276-86.
27. Thorlund K, Imberger G, Walsh M, Chu R, Gluud C, Wetterslev J, Guyatt G, Devereaux PJ, Thabane L. The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysis - a simulation study. PLoS One. 2011;6:e25491.
28. Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User manual for trial sequential analysis (TSA). Copenhagen: Copenhagen Trial Unit, Centre for Clinical Intervention Research; 2011. p. 1-115. Available from http://www.ctu.dk/tsa.
29. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol. 2009;9:86.
30. Higgins J. Convincing evidence from controlled and uncontrolled studies on the lipid-lowering effect of a statin [editorial]. Cochrane Database Syst Rev. 2012;12:ED000049.
31. National Institute for Clinical Excellence. Depression: Mangement of Depression in Primary and Secundary Care. London: National Institute for Clinical Excellence; 2004. p. 640.
32. Byerley WF, Reimherr FW, Wood DR, Grosser BI. Fluoxetine, a selective serotonin uptake inhibitor, for the treatment of outpatients with major depression. J Clin Psychopharmacol. 1988;8:112-5.
33. Davidson JRT, Gadde KM, Fairbank JA, Ranga Rama KK, Califf RM, Binanay C, Parker CB, Pugh N, Hartwell TD, Vitiello B, et al. Effect of Hypericum perforatum (St John's wort) in major depressive disorder: A randomized controlled trial. JAMA. 2002;287(14):10.
34. Fava M, Alpert J, Nierenberg AA, Mischoulon D, Otto MW, Zajecka J, Murck H, Rosenbaum JF. A Double-blind, randomized trial of St John's wort, fluoxetine, and placebo in major depressive disorder. J Clin Psychopharmacol. 2005;25:441-7.
35. Fava M, Amsterdam JD, Deltito JA, Salzman C, Schwaller M, Dunner DL. A double-blind study of paroxetine, fluoxetine, and placebo in outpatients with major depression. Ann Clin Psychiatry. 1998;10:145-50.
36. Feighner JP, Boyer WF, Merideth CH, Hendrickson GG. A double-blind comparison of fluoxetine, imipramine and placebo in outpatients with major depression. Int Clin Psychopharmacol. 1989;4:127-34.
37. Godlewska BR, Norbury R, Selvaraj S, Cowen PJ, Harmer CJ. Short-term SSRI treatment normalises amygdala hyperactivity in depressed patients. Psychol Med. 2012;42:2609-17.
38. Hunter AM, Cook IA, Greenwald SD, Tran ML, Miyamoto KN, Leuchter AF. The antidepressant treatment response index and treatment outcomes in a placebo-controlled trial of fluoxetine. J Clin Neurophysiol. 2011;28:478-82.
39. Itil TM, Shrivastava RK, Mukherjee S. A double-blind placebo-controlled study of fluvoxamine and imipramine in out-patients with primary depression. Brit J Clin Pharmacol. 1983;15(Suppl#3):1983.
40. Jindal RD, Friedman ES, Berman SR, Fasiczka AL, Howland RH, Thase ME. Effects of sertraline on sleep architecture in patients with depression. J Clin Psychopharmacol. 2003;23:540-8.
41. Katz MM, Tekell JL, Bowden CL, Brannan S, Houston JP, Berman N, Frazer A. Onset and early behavioral effects of pharmacologically different antidepressants and placebo in depression. Neuropsychopharmacol. 2004;29:566-79.
42. McGrath PJ, Stewart JW, Janal MN, Petkova E, Quitkin FM, Klein DF. A placebo-controlled study of fluoxetine versus imipramine in the acute treatment of atypical depression. Am J Psychiatry. 2000;157:344-50.
43. Muijen M, Roy D, Silverstone T, Mehmet A, Christie M. A comparative clinical trial of fluoxetine, mianserin and placebo in depressed outpatients. Acta Psychiatr Scand. 1988;78:384-90.
44. Petrakis I, Carroll KM, Nich C, Gordon L, Kosten T, Rounsaville B. Fluoxetine treatment of depressive disorders in methadone-maintained opioid addicts. Drug Alcohol Depend. 1998;50:221-6.
45. Rapaport MH, Schneider LS, Dunner DL, Davies JT, Pitts CD. Efficacy of controlled-release paroxetine in the treatment of late-life depression. J Clin Psychiatry. 2003;64:1065-74.
46. Roth D, Mattes J, Sheehan KH, Sheehan DV. A double-blind comparison of fluvoxamine, desipramine and placebo in outpatients with depression. Prog Neuro Psychopharmacol Biol Psychiat. 1990;14:929-39.
47. Roy A. Placebo-controlled study of sertraline in depressed recently abstinent alcoholics. Biol Psychiatry. 1998;44:633-7.
48. Schneider LS, Nelson JC, Clary CM, Newhouse P, Krishnan KR, Shiovitz T, Weihs K, Sertraline Elderly Depression Study G. An 8-week multicenter, parallel-group, double-blind, placebo-controlled study of sertraline in elderly outpatients with major depression. Am J Psychiatry. 2003;160:1277-85.
49. Sheehan DV, Nemeroff CB, Thase ME, Entsuah R: Placebo-controlled inpatient comparison of venlafaxine and fluoxetine for the treatment of major depression with melancholic features. Int Clin Psychopharmacol 2009, 24(2):March.
50. Mischoulon D, Price LH, Carpenter LL, Tyrka AR, Papakostas GI, Baer L, Dording CM, Clain AJ, Durham K, Walker R, et al. A double-blind, randomized, placebo-controlled clinical trial of S-adenosyl-L-methionine (SAMe) versus escitalopram in major depressive disorder. J Clin Psychiatry. 2014;75(4):370-6.
51. Barber JP, Barrett MS, Gallop R, Rynn MA, Rickels K. Short-term dynamic psychotherapy versus pharmacotherapy for major depressive disorder: a randomized, placebo-controlled trial. J Clin Psychol. 2012;73(1):66-73.
52. Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008;165:617-20.
53. Blumenthal JA, Babyak MA, Doraiswamy PM, Watkins L, Hoffman BM, Barbour KA, Herman S, Craighead WE, Brosse AL, Waugh R, et al. Exercise and pharmacotherapy in the treatment of major depressive disorder. Psychosomatic Med. 2007;69:587-96.
54. Bose A, Li D, Gandhi C. Escitalopram in the acute treatment of depressed patients aged 60 years or older. Am J Geriatr Psychiatry. 2008;16:14-20.
55. Detke MJ, Wiltse CG, Mallinckrodt CH, McNamara RK, Demitrack MA, Bitter I. Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial. Eur Neuropsychopharmacol. 2004;14(6):457-70.
56. Dube S, Dellva MA, Jones M, Kielbasa W, Padich R, Saha A, Rao P: A study of the effects of LY2216684, a selective norepinephrine reuptake inhibitor, in the treatment of major depression. J Psychiatric Res 2010, 44(6):April.
57. Edwards JG, Goldie A. Placebo-controlled trial of paroxetine in depressive illness. Hum Psychopharmacol. 1993;8(3):1993.
58. Fabre LF. A 6-week, double-blind trial of paroxetine, imipramine, and placebo in depressed outpatients. J Clin Psychiatry. 1992;53(Suppl):40-3.
59. Fabre LF, Abuzzahab FS, Amin M, Claghorn JL, Mendels J, Petrie WM, Dub S, Small JG. Sertraline safety and efficacy in major depression: A double-blind fixed-dose comparison with placebo. Biol Psychiatry. 1995;38(9):1995.
60. Higuchi T, Hong JP, Jung HY, Watanabe Y, Kunitomi T, Kamijima K. Paroxetine controlled-release formulation in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled study in Japan and Korea. Psychiatry Clin Neurosci. 2011;65(7):655-63.
61. Kranzler HR, Mueller T, Cornelius J, Pettinati HM, Moak D, Martin PR, Anthenelli R, Brower KJ, O'Malley S, Mason BJ, et al. Sertraline treatment of co-occurring alcohol dependence and major depression. J Clin Psychopharmacol. 2006;26:13-20.
62. Lydiard RB, Stahl SM, Hertzman M, Harrison WM. A double-blind, placebo-controlled study comparing the effects of sertraline versus amitriptyline in the treatment of major depression. J Clin Psychiatry. 1997;58:484-91.
63. Rapaport MH, Lydiard RB, Pitts CD, Schaefer D, Bartolic EI, Iyengar M, Carfagno M, Lipschitz A. Low doses of controlled-release paroxetine in the treatment of late-life depression: a randomized, placebo-controlled trial. J Clin Psychiatry. 2009;70:46-57.
64. Reimherr FW, Chouinard G, Cohn CK, Cole JO, Itil TM, Lapierre YD, Masco HL, Mendels J. Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression. J Clin Psychiatry. 1990;51(Suppl B):18-27.
65. Sramek JJ, Kashkin K, Jasinsky O, Kardatzke D, Kennedy S, Cutler NR. Placebo-controlled study of ABT-200 versus fluoxetine in the treatment of major depressive disorder. Depress. 1995;3(4):1995.
66. Burke WJ, Gergel I, Bose A. Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry. 2002;63:331-6.
67. Cassano GB, Conti L, Massimetti G, Mengali F, Waekelin JS, Levine J. Use of a standardized documentation system (BLIPS/BDP) in the conduct of a multicenter international trial comparing fluvoxamine, imipramine, and placebo. Psychopharmacol Bull. 1986;22:52-8.
68. Cohn JB, Wilcox C. A comparison of fluoxetine, imipramine, and placebo in patients with major depressive disorder. J Clin Psychiatry. 1985;46:26-31.
69. Coleman CC, King BR, Bolden WC, Book MJ, Segraves RT, Richard N, Ascher J, Batey S, Jamerson B, Metz A. A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine. Clin Therapeutics. 2001;23:1040-58.
70. Corrigan MH, Denahan AQ, Wright CE, Ragual RJ, Evans DL. Comparison of pramipexole, fluoxetine, and placebo in patients with major depression. Depress Anxiety. 2000;11:58-65.
71. DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MMBL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005;62:409-16.
72. Dominguez RA, Goldstein BJ, Jacobson AF, Steinbook RM. A double-blind placebo-controlled study of fluvoxamine and imipramine in depression. J Clin Psychiatry. 1985;46:84-7.
73. Fabre LF, Crismon L. Efficacy of fluoxetine in outpatients with major depression. Curr Ther Res Clin Exp. 1985;37(1):1985.
74. Lydiard RB, Laird LK, Morton Jr, Steele TE, Kellner C, Laraia MT, Ballenger JC. Fluvoxamine, imipramine, and placebo in the treatment of depressed outpatients: Effects on depression. Psychopharmacol Bull. 1989;25(1):68.
75. March JS, Kobak KA, Jefferson JW, Mazza J, Greist JH. A double-blind, placebo-controlled trial of fluvoxamine versus imipramine in outpatients with major depression. J Clin Psychiatry. 1990;51:200-2.
76. Mayberg HS, Silva JA, Brannan SK, Tekell JL, Mahurin RK, McGinnis S, Jerabek PA. The functional neuroanatomy of the placebo effect. Am J Psychiatry. 2002;159:728-37.
77. Miller SM, Naylor GJ, Murtagh M, Winslow G. A double-blind comparison of paroxetine and placebo in the treatment of depressed patients in a psychiatric outpatient clinic. Acta Psychiatr Scand. 1989;350:143-4.
78. Nemeroff CB, Thase ME: A double-blind, placebo-controlled comparison of venlafaxine and fluoxetine treatment in depressed outpatients. J Psychiatr Res 2007, 41(3-4):April/June.
79. Norton KR, Sireling LI, Bhat AV, Rao B, Paykel ES: A double-blind comparison of fluvoxamine, imipramine and placebo in depressed patients. J Affect Disord 1984, 7(3-4):Dec.
80. Rickels K, Amsterdam JD, Avallone MF. Fluoxetine in major depression: A controlled study. Curr Ther Res Clin Exp. 1986;39(4):1986.
81. Rudolph RL, Feiger AD. A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression. J Affect Disord. 1999;56:171-81.
82. Schatzberg A, Roose S. A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression. Am J Geriatr Psychiatry. 2006;14:361-70.
83. Shrivastava RK, Shrivastava SH, Overweg N, Blumhardt CL. A double-blind comparison of paroxetine, imipramine, and placebo in major depression. J Clin Psychiatry. 1992;53(Suppl):48-51.
84. Smith WT, Glaudin V. A placebo-controlled trial of paroxetine in the treatment of major depression. J Clin Psychiatry. 1992;53(Suppl):36-9.
85. Tyrer P, Marsden CA, Casey P, Seivewright N. Clinical efficacy of paroxetine in resistant depression. J Psychopharmacol. 1987;1(4):1987.
86. Fabre LF, Putman HP. A fixed-dose clinical trial of fluoxetine in outpatients with major depression. J Clin Psychiatry. 1987;48:406-8.
87. Feighner JP, Boyer WF. Paroxetine in the treatment of depression: a comparison with imipramine and placebo. Acta Psychiatr Scand. 1989;350:125-9.
88. Feighner JP, Boyer WF, Meredith CH, Hendrickson GG. A placebo-controlled inpatient comparison of fluvoxamine maleate and imipramine in major depression. Int Clin Psychopharmacol. 1989;4:239-44.
89. Claghorn JL. The safety and efficacy of paroxetine compared with placebo in a double-blind trial of depressed outpatients. J Clin Psychiatry. 1992;53(Suppl):33-5.
90. Claghorn JL, Earl CQ, Walczak DD, Stoner KA, Wong LF, Kanter D, Houser VP. Fluvoxamine maleate in the treatment of depression: a single-center, double-blind, placebo-controlled comparison with imipramine in outpatients. J Clin Psychopharmacol. 1996;16:113-20.
91. Cohn JB, Crowder JE, Wilcox CS, Ryan PJ. A placebo- and imipramine-controlled study of paroxetine. Psychopharmacol Bull. 1990;26:185-9.
92. Dunbar GC, Cohn JB, Fabre LF, Feighner JP, Fieve RR, Mendels J, Shrivastava RK. A comparison of paroxetine, imipramine and placebo in depressed out-patients. Brit J Psychiatry. 1991;159:394-8.
93. Fabre L, Birkhimer LJ, Zaborny BA, Wong LF, Kapik BM. Fluvoxamine versus imipramine and placebo: a double-blind comparison in depressed patients. Int Clin Psychopharmacol. 1996;11:119-27.
94. Feighner JP, Overõ K. Multicenter, placebo-controlled, fixed-dose study of citalopram in moderate-to-severe depression. J Clin Psychiatry. 1999;60:824-30.
95. Griebel G, Beeské S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012;73:1403-11.
96. Kiev A. A double-blind, placebo-controlled study of paroxetine in depressed outpatients. J Clin Psychiatry. 1992;53(Suppl):27-9.
97. Olie JP, Gunn KP, Katz E. A double-blind placebo-controlled multicentre study of sertraline in the acute and continuation treatment of major depression. Eu Psychiatry. 1997;12(1):1997.
98. Peselow ED, Stanley M, Filippi AM, Barouche F, Goodnick P, Fieve RR. The predictive value of the dexamethasone suppression test. A placebo-controlled study. Brit J Psychiatry. 1989;155:667-72.
99. Rickels K, Amsterdam J, Clary C, Fox I, Schweizer E, Weise C. The efficacy and safety of paroxetine compared with placebo in outpatients with major depression. J Clin Psychiatry. 1992;53(Suppl):30-2.
100. Stahl SM. Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline. Biol Psychiatry. 2000;48:894-901.
101. Trivedi MH, Pigotti TA, Perera P, Dillingham KE, Carfagno ML, Pitts CD. Effectiveness of low doses of paroxetine controlled release in the treatment of major depressive disorder. J Clin Psychiatry. 2004;65:1356-64.
102. Forest Laboratories Inc: SCT-MD-01 (Unpublished Data) Forest Laboratories Inc. Study report from U.S. Food and Drug Administration. 2001.
103. Hoffman BM, Blumenthal JA, Babyak MA, Smith PJ, Rogers SD, Doraiswamy PM, Sherwood A. Exercise fails to improve neurocognition in depressed middle-aged and older adults. Med Sci Sports Exerc. 2008;40:1344-52.
104. Brunoni AR, Valiengo L, Baccaro A, Zanão TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Benseñor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiat. 2013;70:383-91.
105. Kasper S, Ebert B, Larsen K, Tonnoir B. Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder. European Neuropsychopharmacol (conference Publication). 2011;21:S408.
106. Wade A, Michael LO, Bang HK. Escitalopram 10 mg/day is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol. 2002;17:95-102.
107. Silverstone PH, Ravindran A. Once-daily venlafaxine extended release (XR) compared with fluoxetine in outpatients with depression and anxiety. Venlafaxine XR 360 Study Group. J Clin Psychiatry. 1999;60:22-8.
108. Andreoli V, Caillard V, Deo RS, Rybakowski JK, Versiani M. Reboxetine, a new noradrenaline selective antidepressant, is at least as effective as fluoxetine in the treatment of depression. J Clin Psychopharmacol. 2002;22:393-9.
109. O'Flynn K, O'Keane V, Lucey JV, Dinan TG. Effect of fluoxetine on noradrenergic mediated growth hormone release: a double blind, placebo-controlled study. Biol Psychiatry. 1991;30:377-82.
110. Reynolds CF, Smith GS, Dew MA, Mulsant BH, Miller MD, Schlernitzauer M, Stack JA, Houck PR, Pollock BG. Accelerating symptom-reduction in late-life depression: a double-blind, randomized, placebo-controlled trial of sleep deprivation. Am J Geriatr Psychiatry. 2005;13:353-8.
111. Roose SP, Sackeim HA, Krishnan KR, Pollock BG, Alexopoulos G, Lavretsky H, Katz IR, Hakkarainen H, Old Old Depression Study G. Antidepressant pharmacotherapy in the treatment of depression in the very old: a randomized, placebo-controlled trial. Am J Psychiatry. 2004;161:2050-9.
112. Wang G, McIntyre A, Eriksson H. A randomized, double-blind study of the efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder. Neuropsychiatr Dis Treat. 2014, 10.
113. Kasper S, de Swart H, Friis AH. Escitalopram in the treatment of depressed elderly patients. Am J Geriatr Psychiatry. 2005;13:884-91.
114. Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, et al. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012;26:653-62.
115. Mancino MJ, McGaugh J, Chopra MP, Guise JB, Cargile C, Williams DK, Thostenson J, Kosten TR, Sanders N, Oliveto A. Clinical efficacy of sertraline alone and augmented with gabapentin in recently abstinent cocaine-dependent patients with depressive symptoms. J Clin Psychopharmacol. 2014;34:234-9.
116. Pettinati HM, Oslin DW, Kampman KM, Dundon WD, Xie H, Gallis TL, Dackis CA, O'Brien CP. A double-blind, placebo-controlled trial combining sertraline and naltrexone for treating co-occurring depression and alcohol dependence. Am J Psychiatry. 2010;167:668-75.
117. Ratti E, Bellew K, Bettica P, Bryson H, Zamuner S, Archer G, Squassante L, Bye A, Trist D, Krishnan KR, et al. Results from 2 randomized, double-blind, placebo-controlled studies of the novel NK1 receptor antagonist casopitant in patients with major depressive disorder. J Clin Psychopharmacol. 2011;31:727-33.
118. Ravindran AV, Teehan MD, Bakish D, Yatham L, Oreilly R, Fernando ML, Manchanda R, Charbonneau Y, Buttars J. The impact of sertraline, desipramine, and placebo on psychomotor functioning in depression. Human Psychopharmacol. 1995;10(4):273-81.
119. 315 (Unpublished Data). Study report from U.S. Food and Drug Administration. In.; 1991.
120. Adamson SJ, Sellman JD, Foulds J, Frampton CM, Deering D, Dunn A, Berks J, Nixon L, Cape G. A randomized trial of combined citalopram and naltrexone for nonabstinent outpatients with co-occurring alcohol dependence and major depression. J Clin Psychopharmacol. 2015;35:143-9.
121. Ball WA, Snavely DB, Hargreaves RJ, Szegedi A, Lines C, Reines SA. Addition of an Nk1 receptor antagonist to an Ssri did not enhance the antidepressant effects of Ssri monotherapy: results from a randomized clinical trial in patients with major depressive disorder. Hum Psychopharmacol. 2014;29:568-77.
122. Chen YM, Huang XM, Thompson R, Zhao YB. Clinical features and efficacy of escitalopram treatment for geriatric depression. J Int Med Res. 2011;39(5):2011.
123. Clayton AH, Croft H, Horrigan JP, Wightman DS, Krishen A, Richard NE, Modell JG. Bupropion extended release compared with escitalopram: Effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2006;67:736-46.
124. Coleman CC, Cunningham LA, Foster VJ, Batey SR, Donahue RM, Houser TL, Ascher JA. Sexual dysfunction associated with the treatment of depression: a placebo-controlled comparison of bupropion sustained release and sertraline treatment. Ann Clin Psychiatry. 1999;11:205-15.
125. Croft H, Settle E, Houser T, Batey SR, Donahue RM, Ascher JA. A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline. Clin Ther. 1999;21:643-58.
126. Doogan DP, Langdon CJ. A double-blind, placebo-controlled comparison of sertraline and dothiepin in the treatment of major depression in general practice. Int Clin Psychopharmacol. 1994;9:95-100.
127. Fabre LF, Clayton AH, Smith LC, Goldstein I, Derogatis LR. The Effect of Gepirone-ER in the Treatment of Sexual Dysfunction in Depressed Men. J Sex Med. 2012, 9(3):March.
128. Golden RN, Nemeroff CB, McSorley P, Pitts CD, DubÇ EM. Efficacy and tolerability of controlled-release and immediate-release paroxetine in the treatment of depression. J Clin Psychiatry. 2002;63:577-84.
129. Hunter AM, Leuchter AF, Cook IA, Abrams M. Brain functional changes (QEEG cordance) and worsening suicidal ideation and mood symptoms during antidepressant treatment. Acta Psychiatr Scand. 2010;122:461-9.
130. Lepola UM, Loft H, Reines EH. Escitalopram (10-20 mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol. 2003;18:211-7.
131. Leuchter AF, Morgan M, Cook IA, Dunkin J, Abrams M, Witte E. Pretreatment neurophysiological and clinical characteristics of placebo responders in treatment trials for major depression. Psychopharmacology (Berl). 2004;177:15-22.
132. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7.
133. Mao JJ, Xie SX, Zee J, Soeller I, Li QS, Rockwell K, Amsterdam JD. Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial. Phytomedicine. 2015;22:394-9.
134. Mathews M, Gommoll C, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 Mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015;30:67-74.
135. Mendels J, Kiev A, Fabre LF. Double-blind comparison of citalopram and placebo in depressed outpatients with melancholia. Depress Anxiety. 1999;9:54-60.
136. Montgomery SA, Rasmussen JG, Lyby K, Connor P, Tanghõj P. Dose response relationship of citalopram 20 mg, citalopram 40 mg and placebo in the treatment of moderate and severe depression. Int Clin Psychopharmacol. 1992;6 Suppl 5:65-70.
137. MY-1045/BRL-029060/1 (PAR128) (Unpublished Data) GlaxoSmithKline. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison of Paroxetine and Fluoxetine in the Treatment of Major Depressive Disorder. http://www.gsk-clinicalstudyregister.com/files2/2821.pdf 2005, 1:1-5.
138. MY-1043/BRL-029060/115 (Unpublished Data) GlaxoSmithKline. A multicenter, randomized, double-blind, placebo-controlled comparison of paroxetine and fluoxetine in the treatment of major depressive disorder. http://www.gsk-clinicalstudyregister.com/files2/2060.pdf 2005, 175:1-5.
139. Rath A, Ngwabyt S, Durisic S, Garattini S, Neugebauer EAM, Laville M, Jakobsen JC, Kubiac C, DeMotes-Mainard J, Gluud C: Specific barriers to the conduct of randomised clinical trials within rare diseases - the Europeean Clinical Research Infrastructure (ECRIN) perspective. TRIALS, to be submitted 2015.
140. AstraZeneca. AZD7268 Safety and Tolerability Study. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2015 Jun 19]. https://clinicaltrials.gov/ct2/show/results/NCT01020799?term=NCT01020799&rank=1. In.; 2012.
141. Nierenberg, Greist JH, Mallinckrodt CH, Prakash A, Sambunaris A, Tollefson GD, Wohlreich MM. Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: onset of antidepressant action, a non-inferiority study. Curr Med Res Opinion. 2007;23:401-16.
142. PAR 01-001(Unpublished Data). Study report from U.S. Food and Drug Administration. In.; 1992.
143. PAR 09 (Unpublished Data). Study report from U.S. Food and Drug Administration. In.; 1992.
144. Nyth aL, Gottfries CG, Lyby K, Smedegaard-Andersen L, Gylding-Sabroe J, Kristensen M, Refsum HE, Ofsti E, Eriksson S, Syversen S. A controlled multicenter clinical study of citalopram and placebo in elderly depressed patients with and without concomitant dementia. Acta Psychiatr Scand. 1992;86:138-45.
145. PAR 29060.07.001 (Unpublished Data) GlaxoSmithKline. A Double-Blind Comparison of Paroxetine, Amitriptyline, and Placebo in Inpatients with Major Depressive Disorder with Melancholia. http://www.gsk-clinicalstudyregister.com/files2/1866.pdf 2008:1-4.
146. Perahia DGS, Wang F, Mallinckrodt CH, Walker DJ, Detke MJ. Duloxetine in the treatment of major depressive disorder: a placebo- and paroxetine-controlled trial. Eu Psychiatry. 2006;21:367-78.
147. Peselow ED, Lautin A, Wolkin A. The dexamethasone suppression test and response to placebo. J Clin Psychopharmacol. 1986;6(5):1986.
148. Porro V, Fiorenzioni S, Menga C, De CA, Bertolino A. Single-blind comparison of the efficacy of fluvoxamine versus placebo in patients with depressive syndrome. Curr Therapeutic Res. 1988;43(4):1988.
149. SCT-MD-26 (Unpublished Data) Forest Research Institute. Two-week double-blind placebo controlled study of escitalopram in the treatment of severe major depression. 2005, 135:2-4.
150. SCT-MD-27 (Unpublished Data) Forest Research Institute. A double-blind flexible dose comparison of escitalopram sertraline and placebo in the treatment of major depressive disorder. 2005, 91:5-7.
151. SCT-MD-35 (Unpublished Data) Forest Research Institute. Fixed-dose comparison of escitalopram combination in adult patients with major depressive disorder. 2007:1-28.
152. Walczak DD, Apter JT, Halikas JA, Borison RL, Carman JS, Post GL, Patrick R, Cohn JB, Cunningham LA, Rittberg B, et al. The oral dose-effect relationship for fluvoxamine: a fixed-dose comparison against placebo in depressed outpatients. Ann Clin Psychiatry. 1996;8:139-51.
153. Zitman FG, CouvÇe JE. Chronic benzodiazepine use in general practice patients with depression: an evaluation of controlled treatment and taper-off: report on behalf of the Dutch Chronic Benzodiazepine Working Group. Brit J Psychiatry. 2001;178:317-24.
154. Hutton B, Salanti G, Caldwell DM, Chaimani A, Schmid CH, Cameron C, Ioannidis JP, Straus S, Thorlund K, Jansen JP, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med. 2015;162(11):777-84.
155. 29060/785 (Unpublished Data) GlaxoSmithKline. A double-blind, placebo-controlled, fixed-dosage study comparing the efficacy and tolerability of paroxetine CR and citalopram to placebo in the treatment of Major Depressive Disorder with anxiety. http://www.gsk-clinicalstudyregister.com/files2/2202.pdf 2005:1-5.
156. Cornelius JR, Salloum IM, Ehler JG, Jarrett PJ, Cornelius MD, Perel JM, Thase ME, Black A. Fluoxetine in depressed alcoholics. A double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1997;54:700-5.
157. Goldstein DJ, Lu Y, Detke MJ, Wiltse C, Mallinckrodt C, Demitrack M. Duloxetine in the treatment of depression. J Clin Psychopharmacol. 2004;24:389-99.
158. Goldstein DJ, Ph D, Mallinckrodt C, Ph D, Lu Y, Ph D, Demitrack MA. Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. J Clin Psychiatry. 2002;63(3):225-31.
159. Kaddurah-Daouk R, Boyle SH, Matson W, Sharma S, Matson S, Zhu H, Bogdanov MB, Churchill E, Krishnan RR, Rush aJ, et al. Pretreatment metabotype as a predictor of response to sertraline or placebo in depressed outpatients: a proof of concept. Translat Psychiatry. 2011;1:e26.
160. Kennedy S. Flibanserin: initial evidence of efficacy on sexual dysfunction, in patients with major depressive disorder. J Sex Med. 2010;7(10):3449-59.
161. Dubini A, Bosc M, Polin V. Noradrenaline-selective versus serotonin-selective antidepressant therapy: differential effects on social functioning. J Psychopharmacol. 1997;11:S17-23.
162. Tollefson GD, Bosomworth JC, Heiligenstein JH, Potvin JH. A double-blind, placebo-controlled clinical trial of fluoxetine in geriatric patients with major depression. Int Psychogeriatr. 1995;1:89-104.
163. Dunlop SR, Dornseif BE, Wernicke JF, Potvin JH. Pattern analysis shows beneficial effect of fluoxetine treatment in mild depression. Psychopharmacol Bull. 1990;26(2):1.
164. Schmitz JM, Averill P, Stotts AL, Moeller FG, Rhoades HM, Grabowski J. Fluoxetine treatment of cocaine-dependent patients with major depressive disorder. Drug Alcohol Depend. 2001;63:207-14.
165. 89306 (Unpublished Data). Study report from U.S. Food and Drug Administration. In.; 1998.
166. Wakelin JS. Fluvoxamine in the treatment of the older depressed patient; double-blind, placebo-controlled data. Int Clin Psychopharmacol. 1986;1:221-30.
167. 29060/448. 2005:1-6.
168. NKF100096 (Unpublished Data) GlaxoSmithKline. A randomised, double-blind, double-dummy, parallel-group, placebo-controlled, forced dose titration study evaluating the efficacy and safety of a new chemical entity (NCE) and paroxetine in subjects with major depressive disorder (MDD). 2007:4-7.
169. 89303 (Unpublished Data) Forest Laboratories Inc. Study report from U.S. Food and Drug Administration. In.; 1998.
170. Cohn JB, Wilcox CS. Paroxetine in major depression: a double-blind trial with imipramine and placebo. J Clin Psychiatry. 1992;53(Suppl):52-6.
171. Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and cox regression. Am J Epidemiol. 2007;165(6):710-8.
172. Tollefson GD, Holman SL. Analysis of the Hamilton Depression Rating Scale factors from a double-blind, placebo-controlled trial of fluoxetine in geriatric major depression. Int Clin Psychopharmacol. 1993;8:253-9.
173. CIT-MD-03 (Unpublished Data) Forest Laboratories Inc. A randomized double-blind placebo-controlled trial of citalopram in depressed patients at least 75 years of age. 2005:1-4.
174. Bech AT. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561-71.
175. SND103288 (Unpublished Data) GlaxoSmithKline. A ten-week, multicentre, randomised, double-blind, placebo-and active-controlled, parallel-group, flexible-dose study evaluating the efficacy, safety and tolerability of GSK372475, a new chemical entity (NCE), or paroxetine compared to placebo in adult subjects diagnosed with major depressive disorder. URL: http://www.gsk-clinicalstudyregister.com/files2/21101.pdf. 2008:1-9.
176. WELL AK130926 (Unpublished Data) GlaxoSmithKline. A multicenter, double-blind, randomized, placebo-controlled comparison of the effects on sexual functioning of extended-release bupropion hydrochloride (300-450 mg) and escitalopram (10-20 mg) in outpatients with moderate to severe major depression over an eight-week treatment period. URL: http://www.gsk-clinicalstudyregister.com/files2/20466.pdf. 2007.
177. Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med. 2004;23(9):1351-75.
178. Forest Laboratories Inc: SCT-MD-01. Unpublished 2001, Study report from FDA.
179. 29060/810. 2005:1-7.
180. Forest Laboratories. Safety and efficacy of vilazodone in major depressive disorder (VLZ-MD-01). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2015 Jun 19]. Available from: http://clinicaltrials.gov/show/NCT01473381 URL: https://clinicaltrials.gov/ct2/show/results/NCT01473381?term=NCT01473381&rank=1. In.; 2014.
181. SCT-MD-02 (Unpublished Data) Forest Laboratories Inc. Study report from U.S. Food and Drug Administration. In.; 2002.
182. Broich K. Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants. Eur Neuropsychopharmacol. 2009;19(5):305-8.
183. Hunt SM, McKenna SP. The QLDS: a scale for the measurement of quality of life in depression. Health Policy. 1992;22(3):307-19.
184. Jakobsen JC, Gluud C. The necessity of randomized clinical trials. Br J Med Res. 2013;3(4):1453-68.
185. Rimer J, Dwan K, Lawlor Debbie A, Greig Carolyn A, McMurdo M, Morley W, Mead Gillian E. Exercise for depression. Coch Database Syst Rev. 2012;7:CD004366. pub004366.
186. Leucht S, Fennema H, Engel R, Kaspers-Janssen M, Lepping P, Szegedi A. What does the HAMD mean? J Affect Disord. 2013;148(2-3):243-8.
187. Moncrieff J, Kirsch I. Empirically derived criteria cast doubt on the clinical significance of antidepressant-placebo differences. Contemp Clin Trials. 2015;43:60-2.
188. Furukawa TA, Cipriani A, Atkinson LZ, Leucht S, Ogawa Y, Takeshima N, Hayasaka Y, Chaimani A, Salanti G. Placebo response rates in antidepressant trials: a systematic review of published and unpublished double-blind randomised controlled studies. Lancet Psychiatry. 2016;3(11):1059-66.
189. Hrobjartsson A, Gotzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev. 2010;1:CD003974.
190. Hrobjartsson A, Emanuelsson F, Skou Thomsen AS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol. 2014;43(4):1272-83.
191. Hróbjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Hilden J, Boutron I, Ravaud P, Brorson S. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ. 2012;344:e1119.
192. Hróbjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Hilden J, Boutron I, Ravaud P, Brorson S. Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors. CMAJ. 2013;185(4):E201-11.
193. Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Coch Database Syst Rev. 2012;12:MR000033.
194. Savovic J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, Als-Nielsen B, Balk EM, Gluud C, Gluud LL, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012;157(6):429-38.
195. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408-12.
196. Sutton AJ, Duval SJ, Tweedie RL, Abrams KR, Jones DR. Empirical assessment of effect of publication bias on meta-analyses. BMJ. 2000;320(7249):1574-7.
197. Garattini S, Jakobsen JC, Wetterslev J, Bertele' V, Banzi R, Rath A, Neugebauer EAM, Laville M, Masson Y, Hivert V et al. Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them. Eur J Internal Med. 2016;32:13-21.
198. Krogh J, Hjorthoj CR, Jakobsen JC, Lindschou J, Kessing LV, Nordentoft M, Gluud C. DEPERROR: Risks of systematic errors in drug and non-drug randomized clinical trials assessing intervention effects in patients with unipolar depression. J Affect Disord. 2015;179:121-7.
199. Ragland DR. Dichotomizing continuous outcome variables: dependence of the magnitude of association and statistical power on the cutpoint. Epidemiol. 1992;3(5):434-40.
200. Dawson NV, Weiss R: Dichotomizing continuous variables in statistical analysis. A practice to avoid. Med Decis Making 2012, 32(225).
201. Altman DG, Royston P. The cost of dichotomising continuous variables. BMJ. 2006;332(7549):1080.
202. Kirsch I, Moncrieff J. Clinical trials and the response rate illusion. Contemp Clin Trials. 2007;28(4):348-51.
203. Leucht S, Hierl S, Kissling W, Dold M, Davis JM. Putting the efficacy of psychiatric and general medicine medication into perspective: review of meta-analyses. Br J Psychiatry. 2012;200(2):97-106.
204. Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta-analyses may be inconclusive--Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. Int J Epidemiol. 2009;38(1):287-98.
205. Savović J, Jones H, Altman D, Harris R, Juni P, Pildal J, Nielsen B, Balk E, Gluud C, Gluud L, et al. Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials: combined analysis of meta-epidemiologic studies. Health Technol Assess. 2012;16(35):1-82.
206. Andrews P, Thomson JA, Amstadter A, Neale M. Primum Non Nocere: An Evolutionary Analysis of Whether Antidepressants Do More Harm than Good. Front Psychol. 2012, 3(117).
207. Gøtzsche PC: Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare: Radcliffe Medical Press ltd; 2013.
208. Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, Watanabe N, Nakagawa A, Omori IM, McGuire H, et al. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009;373(9665):746-58.