No role for initial severity on the efficacy of antidepressants: Results of a multi-meta-analysis

Annals of General Psychiatry

Volumn 12, Issue 1, 2013, Pages

  Fountoulakis, Konstantinos N ^a   Veroniki, Areti Angeliki ^b   Siamouli, Melina ^a   Möller, Hans Jürgen ^c  

^a ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^b UNIVERSITY OF IOANNINA   (Greece)

^c UNIVERSITY OF MUNICH   (Germany)

Author keywords

Antidepressants; Baseline severity; Depression; Effect size; Meta analysis

Indexed keywords

FLUOXETINE; NEFAZODONE; PAROXETINE; PLACEBO; VENLAFAXINE;

DRUG EFFICACY; EFFECT SIZE; HUMAN; MANIA; MAXIMUM LIKELIHOOD METHOD; META ANALYSIS; REVIEW; SCHIZOPHRENIA; TREATMENT OUTCOME;

EID: 84881281446     PISSN: None     EISSN: 1744859X     Source Type: Journal    
DOI: 10.1186/1744-859X-12-26     Document Type: Review

References (84)

1. 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):252-260. 10.1056/NEJMsa065779, 18199864.
2. Ghaemi SN. Why antidepressants are not antidepressants: STEP-BD, STAR*D, and the return of neurotic depression. Bipolar Disord 2008, 10(8):957-968. 10.1111/j.1399-5618.2008.00639.x, 19594510.
3. Bech P, Cialdella P, Haugh MC, Birkett MA, Hours A, Boissel JP, Tollefson GD. Meta-analysis of randomised controlled trials of fluoxetine v. placebo and tricyclic antidepressants in the short-term treatment of major depression. Br J Psychiatry 2000, 176:421-428. 10.1192/bjp.176.5.421, 10912216.
4. Moncrieff J, Wessely S, Hardy R. Active placebos versus antidepressants for depression. Cochrane Database Syst Rev 2004, 1. CD003012.
5. 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. 10.1371/journal.pmed.0050045, 2253608, 18303940.
6. 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. 10.1001/jama.2009.1943, 3712503, 20051569.
7. Barbui C, Furukawa TA, Cipriani A. Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials. CMAJ 2008, 178(3):296-305. 2211353, 18227449.
8. 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):40-45. 10.1097/00004714-200202000-00007, 11799341.
9. Undurraga J, Baldessarini RJ. Randomized, placebo-controlled trials of antidepressants for acute major depression: thirty-year meta-analytic review. Neuropsychopharmacology 2012, 37(4):851-864. 10.1038/npp.2011.306, 3280655, 22169941.
10. Kirsch I. Antidepressants and the placebo response. Epidemiol Psichiatr Soc 2009, 18(4):318-322. 10.1017/S1121189X00000282, 20170046.
11. Kirsch I. The Emperor's New Drugs: Exploding the Antidepressant Myth 2009, London: The Bodley Head.
12. Fountoulakis KN, Hoschl C, Kasper S, Lopez-Ibor J, Moller HJ. The media and intellectuals' response to medical publications: the anti-depressants' case. Ann Gen Psychiatry 2013, 12(1):11. 10.1186/1744-859X-12-11, 3643832, 23587303.
13. Cuijpers P, Clignet F, Van Meijel B, Van Straten A, Li J, Andersson G. Psychological treatment of depression in inpatients: a systematic review and meta-analysis. Clin Psychol Rev 2011, 31(3):353-360. 10.1016/j.cpr.2011.01.002, 21382540.
14. Cuijpers P, Smit F, Bohlmeijer E, Hollon SD, Andersson G. Efficacy of cognitive-behavioural therapy and other psychological treatments for adult depression: meta-analytic study of publication bias. Br J Psychiatry 2010, 196(3):173-178. 10.1192/bjp.bp.109.066001, 20194536.
15. Cuijpers P, Van Straten A, Bohlmeijer E, Hollon SD, Andersson G. The effects of psychotherapy for adult depression are overestimated: a meta-analysis of study quality and effect size. Psychol Med 2009, 40(2):211-223.
16. Driessen E, Cuijpers P, Hollon SD, Dekker JJ. Does pretreatment severity moderate the efficacy of psychological treatment of adult outpatient depression? A meta-analysis. J Consult Clin Psychol 2010, 78(5):668-680.
17. Thase ME, Larsen KG, Kennedy SH. Assessing the 'true' effect of active antidepressant therapy v. placebo in major depressive disorder: use of a mixture model. Br J Psychiatry 2011, 199:501-507. 10.1192/bjp.bp.111.093336, 22130749.
18. Fountoulakis KN, Moller HJ. Efficacy of antidepressants: a re-analysis and re-interpretation of the Kirsch data. Int J Neuropsychopharmacol 2011, 14(3):405-412. 10.1017/S1461145710000957, 20800012.
19. Horder J, Matthews P, Waldmann R. Placebo, prozac and PLoS: significant lessons for psychopharmacology. J Psychopharmacol 2011, 25(10):1277-1288. 10.1177/0269881110372544, 20571143.
20. Khan A, Warner HA, Brown WA. Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration database. Arch Gen Psychiatry 2000, 57(4):311-317. 10.1001/archpsyc.57.4.311, 10768687.
21. Barrett JE, Williams JW, Oxman TE, Frank E, Katon W, Sullivan M, Hegel MT, Cornell JE, Sengupta AS. Treatment of dysthymia and minor depression in primary care: a randomized trial in patients aged 18 to 59 years. J Fam Pract 2001, 50(5):405-412.
22. DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry 2005, 62(4):409-416. 10.1001/archpsyc.62.4.409, 15809408.
23. Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol 2006, 74(4):658-670.
24. Elkin I, Shea MT, Watkins JT, Imber SD, Sotsky SM, Collins JF, Glass DR, Pilkonis PA, Leber WR, Docherty JP. National Institute of Mental Health Treatment of Depression Collaborative Research Program. General effectiveness of treatments. Arch Gen Psychiatry 1989, 46(11):971-982. discussion 983, 10.1001/archpsyc.1989.01810110013002, 2684085.
25. Philipp M, Kohnen R, Hiller KO. Hypericum extract versus imipramine or placebo in patients with moderate depression: randomised multicentre study of treatment for eight weeks. BMJ 1999, 319(7224):1534-1538. 10.1136/bmj.319.7224.1534, 28296, 10591711.
26. Khan A, Khan SR, Leventhal RM, Krishnan KR, Gorman JM. An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics. Biol Psychiatry 2002, 52(1):62-67. 10.1016/S0006-3223(02)01322-7, 12079731.
27. Huedo-Medina T, Johnson B, Kirsch I. Kirsch et al. (2008) calculations are correct: reconsidering Fountoulakis & Moller's re-analysis of the Kirsch data. Int J Neuropsychopharmacol 2012, 15:1193-1198. 10.1017/S1461145711001878, 22433169.
28. Caldwell DM, Ades AE, Higgins JP. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 2005, 331(7521):897-900. 10.1136/bmj.331.7521.897, 1255806, 16223826.
29. Cooper NJ, Peters J, Lai MC, Juni P, Wandel S, Palmer S, Paulden M, Conti S, Welton NJ, Abrams KR, Bujkiewicz S, Spiegelhalter D, Sutton AJ. How valuable are multiple treatment comparison methods in evidence-based health-care evaluation?. Value Health 2011, 14(2):371-380. 10.1016/j.jval.2010.09.001, 21296599.
30. Mills EJ, Ghement I, O'Regan C, Thorlund K. Estimating the power of indirect comparisons: a simulation study. PLoS One 2011, 6(1):e16237. 10.1371/journal.pone.0016237, 3025012, 21283698.
31. White IR. Multivariate random-effects meta-regression: updates to mvmeta. Stata Journal 2011, 11:255-270.
32. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol 2011, 64(2):163-171. 10.1016/j.jclinepi.2010.03.016, 20688472.
33. Lambert P, Eilers PH. Bayesian proportional hazards model with time-varying regression coefficients: a penalized Poisson regression approach. Stat Med 2005, 24(24):3977-3989. 10.1002/sim.2396, 16320263.
34. Lambert PC, Sutton AJ, Burton PR, Abrams KR, Jones DR. How vague is vague? A simulation study of the impact of the use of vague prior distributions in MCMC using WinBUGS. Stat Med 2005, 24(15):2401-2428. 10.1002/sim.2112, 16015676.
35. Friedrich JO, Adhikari NK, Beyene J. Ratio of means for analyzing continuous outcomes in meta-analysis performed as well as mean difference methods. J Clin Epidemiol 2011, 64(5):556-564. 10.1016/j.jclinepi.2010.09.016, 21447428.
36. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions 2011, The Cochrane Collaboration, http://www.cochrane-handbook.org.
37. Sutton AJ, Abrams KR. Bayesian methods in meta-analysis and evidence synthesis. Stat Methods Med Res 2001, 10(4):277-303. 10.1191/096228001678227794, 11491414.
38. Sharp SJ, Thompson SG. Analysing the relationship between treatment effect and underlying risk in meta-analysis: comparison and development of approaches. Stat Med 2000, 19(23):3251-3274. 10.1002/1097-0258(20001215)19:23<3251::AID-SIM625>3.0.CO;2-2, 11113958.
39. Thompson SG, Smith TC, Sharp SJ. Investigating underlying risk as a source of heterogeneity in meta-analysis. Stat Med 1997, 16(23):2741-2758. 10.1002/(SICI)1097-0258(19971215)16:23<2741::AID-SIM703>3.0.CO;2-0, 9421873.
40. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol 2010, 64(2):163-171.
41. Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Stat Med 2002, 21(11):1575-1600. 10.1002/sim.1188, 12111921.
42. Engels EA, Schmid CH, Terrin N, Olkin I, Lau J. Heterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analyses. Stat Med 2000, 19(13):1707-1728. 10.1002/1097-0258(20000715)19:13<1707::AID-SIM491>3.0.CO;2-P, 10861773.
43. Kirsch I. Placebo psychotherapy: synonym or oxymoron?. J Clin Psychol 2005, 61(7):791-803. 10.1002/jclp.20126, 15827992.
44. Kirsch I. Conditioning, expectancy, and the placebo effect: comment on Stewart-Williams and Podd (2004). Psychol Bull 2004, 130(2):341-343. discussion 344-345.
45. Kirsch I, Johnson BT. Moving beyond depression: how full is the glass?. BMJ 2008, 336(7645):629-630. 2270972, 18356213.
46. Kirsch I. Antidepressant drugs 'work' , but they are not clinically effective. Br J Hosp Med (Lond) 2008, 69(6):359.
47. Kirsch I. Challenging received wisdom: antidepressants and the placebo effect. Mcgill J Med 2008, 11(2):219-222. 2582668, 19148327.
48. Kirsch I, Moncrieff J. Clinical trials and the response rate illusion. Contemp Clin Trials 2007, 28(4):348-351. 10.1016/j.cct.2006.10.012, 17182286.
49. Fountoulakis KN, Moller HJ. Antidepressant drugs and the response in the placebo group: the real problem lies in our understanding of the issue. J Psychopharmacol 2011, 26(5):744-750.
50. Fountoulakis K, Möller H. Antidepressants vs. placebo: not merely a quantitative difference in response. Int J Neuropsychopharmacol 2011, 14:1435-1437.
51. Glenny AM, Altman DG, Song F, Sakarovitch C, Deeks JJ, D'Amico R, Bradburn M, Eastwood AJ. Indirect comparisons of competing interventions. Health Technol Assess 2005, 9(26):1-134. iii-iv.
52. Song F, Altman DG, Glenny AM, Deeks JJ. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 2003, 326(7387):472. 10.1136/bmj.326.7387.472, 150178, 12609941.
53. Song F, Loke YK, Walsh T, Glenny AM, Eastwood AJ, Altman DG. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ 2009, 338:b1147. 10.1136/bmj.b1147, 2665205, 19346285.
54. 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. 10.1192/bjp.bp.111.096594, 22297588.
55. Cohen J. A power primer. Psychol Bull 1992, 112(1):155-159.
56. Tarr GP, Glue P, Herbison P. Comparative efficacy and acceptability of mood stabilizer and second generation antipsychotic monotherapy for acute mania - a systematic review and meta-analysis. J Affect Disord 2011, 143(1-3):14-19.
57. Yildiz A, Vieta E, Leucht S, Baldessarini RJ. Efficacy of antimanic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology 2011, 36(2):375-389. 10.1038/npp.2010.192, 3055677, 20980991.
58. Leucht S, Arbter D, Engel RR, Kissling W, Davis JM. How effective are second-generation antipsychotic drugs? A meta-analysis of placebo-controlled trials. Mol Psychiatry 2009, 14(4):429-447. 10.1038/sj.mp.4002136, 18180760.
59. Oldham P. A note on the analysis of repeated measurements of the same subjects. J Chronic Dis 1962, 15:969-977. 10.1016/0021-9681(62)90116-9, 13939936.
60. Tu YK, Maddick IH, Griffiths GS, Gilthorpe MS. Mathematical coupling can undermine the statistical assessment of clinical research: illustration from the treatment of guided tissue regeneration. J Dent 2004, 32(2):133-142. 10.1016/j.jdent.2003.10.001, 14749085.
61. Cuijpers P, Van Straten A, Van Oppen P, Andersson G. Are psychological and pharmacologic interventions equally effective in the treatment of adult depressive disorders? A meta-analysis of comparative studies. J Clin Psychiatry 2008, 69(11):1675-1685. quiz 1839-1641, 10.4088/JCP.v69n1102, 18945396.
62. Blomqvist N. On the relation between change and initial value. J Am Stat Assoc 1977, 72:746-749.
63. Jin P. Toward a reconceptualization of the law of initial value. Psychol Bull 1992, 111:176-184.
64. Goodman SN. Toward evidence-based medical statistics. 2: the Bayes factor. Ann Intern Med 1999, 130(12):1005-1013. 10.7326/0003-4819-130-12-199906150-00019, 10383350.
65. Goodman SN. Toward evidence-based medical statistics. 1: the P value fallacy. Ann Intern Med 1999, 130(12):995-1004. 10.7326/0003-4819-130-12-199906150-00008, 10383371.
66. Johnson SR, Tomlinson GA, Hawker GA, Granton JT, Feldman BM. Methods to elicit beliefs for Bayesian priors: a systematic review. J Clin Epidemiol 2009, 63(4):355-369.
67. 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):572-579. 10.1001/archgenpsychiatry.2011.2044, 3371295, 22393205.
68. Melander H, Salmonson T, Abadie E, Van Zwieten-Boot B. A regulatory apologia-a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants. Eur Neuropsychopharmacol 2008, 18(9):623-627. 10.1016/j.euroneuro.2008.06.003, 18621509.
69. Petkova E, Tarpey T, Huang L, Deng L. Interpreting meta-regression: application to recent controversies in antidepressants' efficacy. Stat Med 2013, 32(17):2875-2892. 10.1002/sim.5766, 23440635.
70. Turner EH, Rosenthal R. Efficacy of antidepressants. BMJ 2008, 336(7643):516-517. 10.1136/bmj.39510.531597.80, 2265347, 18319297.
71. Bech P. Rating scales for affective disorders: their validity and consistency. Acta Psychiatr Scand Suppl 1981, 295:1-101.
72. Bech P. Assessment scales for depression: the next 20 years. Acta Psychiatr Scand Suppl 1983, 310:117-130.
73. Bech P. The instrumental use of rating scales for depression. Pharmacopsychiatry 1984, 17(1):22-28. 10.1055/s-2007-1017402, 6709700.
74. Bech P. Rating scales in psychopharmacology. Statistical aspects. Acta Psychiatr Belg 1988, 88(4):291-302.
75. Bech P. Rating scales for mood disorders: applicability, consistency and construct validity. Acta Psychiatr Scand Suppl 1988, 345:45-55.
76. Bech P. Psychometric developments of the Hamilton scales: the spectrum of depression, dysthymia, and anxiety. Psychopharmacol Ser 1990, 9:72-79.
77. Bech P. Modern psychometrics in clinimetrics: impact on clinical trials of antidepressants. Psychother Psychosom 2004, 73(3):134-138. 10.1159/000076448, 15031583.
78. Bech P. Rating scales in depression: limitations and pitfalls. Dialogues Clin Neurosci 2006, 8(2):207-215. 3181766, 16889106.
79. Bech P. Applied psychometrics in clinical psychiatry: the pharmacopsychometric triangle. Acta Psychiatr Scand 2009, 120(5):400-409. 10.1111/j.1600-0447.2009.01445.x, 19807722.
80. Bech P, Allerup P, Gram LF, Reisby N, Rosenberg R, Jacobsen O, Nagy A. The Hamilton depression scale. Evaluation of objectivity using logistic models. Acta Psychiatr Scand 1981, 63(3):290-299. 10.1111/j.1600-0447.1981.tb00676.x, 7015793.
81. Bech P, Gram LF, Dein E, Jacobsen O, Vitger J, Bolwig TG. Quantitative rating of depressive states. Acta Psychiatr Scand 1975, 51(3):161-170. 10.1111/j.1600-0447.1975.tb00002.x, 1136841.
82. Bagby RM, Ryder AG, Schuller DR, Marshall MB. The Hamilton Depression Rating Scale: has the gold standard become a lead weight?. Am J Psychiatry 2004, 161(12):2163-2177. 10.1176/appi.ajp.161.12.2163, 15569884.
83. The Epidemic of Mental Illness: Why?. http://www.nybooks.com/articles/archives/2011/jun/23/epidemic-mental-illness-why/?pagination=false.
84. The Illusions of Psychiatry. http://www.nybooks.com/articles/archives/2011/jul/14/illusions-of-psychiatry/?pagination=false.