Placebo response of non-pharmacological and pharmacological trials in major depression: A systematic review and meta-analysis

PLoS ONE

Volumn 4, Issue 3, 2009, Pages

  Brunoni, André Russowsky ^a,b   Lopes, Mariana ^a   Kaptchuk, Ted J ^a   Fregni, Felipe ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

ESCITALOPRAM; PLACEBO; ANTIDEPRESSANT AGENT; CITALOPRAM; SEROTONIN UPTAKE INHIBITOR;

AGE DISTRIBUTION; CLINICAL TRIAL; COCHRANE LIBRARY; CONTROLLED CLINICAL TRIAL; EFFECT SIZE; HUMAN; MAJOR DEPRESSION; MEDLINE; META ANALYSIS; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIAL; REVIEW; SCORING SYSTEM; SEX DIFFERENCE; SYSTEMATIC REVIEW; TRANSCRANIAL MAGNETIC STIMULATION; TREATMENT RESPONSE; DOUBLE BLIND PROCEDURE;

ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CITALOPRAM; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; HUMANS; PLACEBOS; SEROTONIN UPTAKE INHIBITORS;

EID: 62849104597     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0004824     Document Type: Review

References (74)

1. Walsh BT, Seidman SN, Sysko R, Gould M (2002) Placebo response in studies of major depression: variable, substantial, and growing. Jama 287: 1840-1847.
2. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, et al. (2008) Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 5: e45.
3. Martin JL, Barbanoj MJ, Schlaepfer TE, Thompson E, Perez V, et al. (2003) Repetitive transcranial magnetic stimulation for the treatment of depression. Systematic review and meta-analysis. Br J Psychiatry 182: 480-491.
4. Couturier JL (2005) Efficacy of rapid-rate repetitive transcranial magnetic stimulation in the treatment of depression: a systematic review and meta-analysis. J Psychiatry Neurosci 30: 83-90.
5. Gross M, Nakamura L, Pascual-Leone A, Fregni F (2007) Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. Acta Psychiatr Scand 116: 165-173.
6. Schutter DJ (2008) Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med. pp 1-11.
7. Herrmann LL, Ebmeier KP (2006) Factors modifying the efficacy of transcranial magnetic stimulation in the treatment of depression: a review. J Clin Psychiatry 67: 1870-1876.
8. Kaptchuk TJ, Goldman P, Stone DA, Stason WB (2000) Do medical devices have enhanced placebo effects? J Clin Epidemiol 53: 786-792.
9. Posternak MA, Zimmerman M (2007) Therapeutic effect of follow-up assessments on antidepressant and placebo response rates in antidepressant efficacy trials: meta-analysis. Br J Psychiatry 190: 287-292.
10. Stolk P, Ten Berg MJ, Hemels ME, Einarson TR (2003) Meta-analysis of placebo rates in major depressive disorder trials. Ann Pharmacother 37: 1891-1899.
11. Burke WJ, Gergel I, Bose A (2002) Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry 63: 331-336.
12. Clayton AH, Croft HA, Horrigan JP, Wightman DS, Krishen A, et al. (2006) Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry 67: 736-746.
13. Rapaport MH, Bose A, Zheng H (2004) Escitalopram continuation treatment prevents relapse of depressive episodes. J Clin Psychiatry 65: 44-49.
14. Bose A, Li D, Gandhi C (2008) Escitalopram in the acute treatment of depressed patients aged 60 years or older. Am J Geriatr Psychiatry 16: 14-20.
15. Ninan P, Ventura D, Wang J. Escitalopram is effective and well tolerated in the treatment of severe depression. 2003; San Francisco, USA.
16. Alexopoulos G, Gordon J, Zhang D. A placebo-controlled trial of escitalopram and sertraline in the treatment of major depressive disorder. 2004; San Juan, Puerto Rico.
17. Kasper S, de Swart H, Friis Andersen H (2005) Escitalopram in the treatment of depressed elderly patients. Am J Geriatr Psychiatry 13: 884-891.
18. Nierenberg AA, Greist JH, Mallinckrodt CH, Prakash A, Sambunaris A, et al. (2007) 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 Opin 23: 401-416.
19. Higgins J, Green S, Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 (updated February 2008) The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.
20. Poulet E, Brunelin J, Boeuve C, Lerond J, D'Amato T, et al. (2004) Repetitive transcranial magnetic stimulation does not potentiate antidepressant treatment. Eur Psychiatry 19: 382-383.
21. Herwig U, Lampe Y, Juengling FD, Wunderlich A, Walter H, et al. (2003) Addon rTMS for treatment of depression: a pilot study using stereotaxic coil-navigation according to PET data. J Psychiatr Res 37: 267-275.
22. Rossini D, Lucca A, Zanardi R, Magri L, Smeraldi E (2005) Transcranial magnetic stimulation in treatment-resistant depressed patients: a double-blind, placebo-controlled trial. Psychiatry Res 137: 1-10.
23. Jorge RE, Moser DJ, Acion L, Robinson RG (2008) Treatment of vascular depression using repetitive transcranial magnetic stimulation. Arch Gen Psychiatry 65: 268-276.
24. Egger M, Davey Smith G, Schneider M, Minder C (1997) Bias in meta-analysis detected by a simple, graphical test. Bmj 315: 629-634.
25. Bretlau LG, Lunde M, Lindberg L, Unden M, Dissing S, et al. (2008) Repetitive transcranial magnetic stimulation (rTMS) in combination with escitalopram in patients with treatment-resistant major depression: a double-blind, randomised, sham-controlled trial. Pharmacopsychiatry 41: 41-47.
26. O'Reardon JP, Cristancho P, Pilania P, Bapatla KB, Chuai S, et al. (2007) Patients with a major depressive episode responding to treatment with repetitive transcranial magnetic stimulation (rTMS) are resistant to the effects of rapid tryptophan depletion. Depress Anxiety 24: 537-544.
27. Altshuler LL, Frye MA, Gitlin MJ (2003) Acceleration and augmentation strategies for treating bipolar depression. Biol Psychiatry 53: 691-700.
28. Hoppner J, Schulz M, Irmisch G, Mau R, Schlafke D, et al. (2003) Antidepressant efficacy of two different rTMS procedures. High frequency over left versus low frequency over right prefrontal cortex compared with sham stimulation. Eur Arch Psychiatry Clin Neurosci 253: 103-109.
29. Loo CK, Mitchell PB, McFarquhar TF, Malhi GS, Sachdev PS (2007) A sham-controlled trial of the efficacy and safety of twice-daily rTMS in major depression. Psychol Med 37: 341-349.
30. Herwig U, Fallgatter AJ, Hoppner J, Eschweiler GW, Kron M, et al. (2007) Antidepressant effects of augmentative transcranial magnetic stimulation: randomised multicentre trial. Br J Psychiatry 191: 441-448.
31. Fitzgerald PB, Benitez J, de Castella A, Daskalakis ZJ, Brown TL, et al. (2006) A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry 163: 88-94.
32. Fitzgerald PB, Brown TL, Marston NA, Daskalakis ZJ, De Castella A, et al. (2003) Transcranial magnetic stimulation in the treatment of depression: a double-blind, placebo-controlled trial. Arch Gen Psychiatry 60: 1002-1008.
33. Loo CK, Mitchell PB, Croker VM, Malhi GS, Wen W, et al. (2003) Doubleblind controlled investigation of bilateral prefrontal transcranial magnetic stimulation for the treatment of resistant major depression. Psychol Med 33: 33-40.
34. Anderson IM, Delvai NA, Ashim B, Ashim S, Lewin C, et al. (2007) Adjunctive fast repetitive transcranial magnetic stimulation in depression. Br J Psychiatry 190: 533-534.
35. Stein DJ, Baldwin DS, Dolberg OT, Despiegel N, Bandelow B (2006) Which factors predict placebo response in anxiety disorders and major depression? An analysis of placebo-controlled studies of escitalopram. J Clin Psychiatry 67: 1741-1746.
36. Walach H (2001) The efficacy paradox in randomized controlled trials of CAM and elsewhere: beware of the placebo trap. J Altern Complement Med 7: 213-218.
37. Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, et al. (2006) Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ 332: 391-397.
38. de Craen AJ, Tijssen JG, de Gans J, Kleijnen J (2000) Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol 247: 183-188.
39. Schwartz NA, Turturro MA, Istvan DJ, Larkin GL (2000) Patients' perceptions of route of nonsteroidal anti-inflammatory drug administration and its effect on analgesia. Acad Emerg Med 7: 857-861.
40. Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, et al. (2006) Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry 163: 1905-1917.
41. Lam RW, Chan P, Wilkins-Ho M, Yatham LN (2008) Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and metaanalysis. Can J Psychiatry 53: 621-631.
42. Baethge C, Smolka MN, Gruschka P, Berghofer A, Schlattmann P, et al. (2003) Does prophylaxis-delay in bipolar disorder influence outcome? Results from a long-term study of 147 patients. Acta Psychiatr Scand 107: 260-267.
43. Papakostas GI, Shelton RC, Smith J, Fava M (2007) Augmentation of antidepressants with atypical antipsychotic medications for treatment-resistant major depressive disorder: a meta-analysis. J Clin Psychiatry 68: 826-831.
44. Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, et al. (2007) Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 4: e61.
45. Fergusson D, Glass KC, Waring D, Shapiro S (2004) Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. Bmj 328: 432.
46. Hrobjartsson A (2002) What are the main methodological problems in the estimation of placebo effects? J Clin Epidemiol 55: 430-435.
47. Schulz KF, Chalmers I, Hayes RJ, Altman DG (1995) Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Jama 273: 408-412.
48. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, et al. (1998) Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 352: 609-613.
49. Woods SW, Gueorguieva RV, Baker CB, Makuch RW (2005) Control group bias in randomized atypical antipsychotic medication trials for schizophrenia. Arch Gen Psychiatry 62: 961-970.
50. Trivedi MH, Rush H (1994) Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications? Neuropsychopharmacology 11: 33-43.
51. Fregni F, Simon DK, Wu A, Pascual-Leone A (2005) Non-invasive brain stimulation for Parkinson's disease: a systematic review and meta-analysis of the literature. J Neurol Neurosurg Psychiatry 76: 1614-1623.
52. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008) Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 358: 252-260.
53. Loo CK, Taylor JL, Gandevia SC, McDarmont BN, Mitchell PB, et al. (2000) Transcranial magnetic stimulation (TMS) in controlled treatment studies: are some "sham" forms active? Biol Psychiatry 47: 325-331.
54. Fregni F, Marcolin MA, Myczkowski M, Amiaz R, Hasey G, et al. (2006) Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. Int J Neuropsychopharmacol 9: 641-654.
55. Mitchell PB, Loo CK (2006) Transcranial magnetic stimulation for depression. Aust N Z J Psychiatry 40: 406-413.
56. Lisanby SH, Husain MM, Rosenquist PB, Maixner D, Gutierrez R, et al. (2008) Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial. Neuropsychopharmacology.
57. Boutros NN, Gueorguieva R, Hoffman RE, Oren DA, Feingold A, et al. (2002) Lack of a therapeutic effect of a 2-week sub-threshold transcranial magnetic stimulation course for treatment-resistant depression. Psychiatry Res 113: 245-254.
58. Koerselman F, Laman DM, van Duijn H, van Duijn MA, Willems MA (2004) A 3-month, follow-up, randomized, placebo-controlled study of repetitive transcranial magnetic stimulation in depression. J Clin Psychiatry 65: 1323-1328.
59. Holtzheimer PE 3rd, Russo J, Claypoole KH, Roy-Byrne P, Avery DH (2004) Shorter duration of depressive episode may predict response to repetitive transcranial magnetic stimulation. Depress Anxiety 19: 24-30.
60. Jorge RE, Robinson RG, Tateno A, Narushima K, Acion L, et al. (2004) Repetitive transcranial magnetic stimulation as treatment of poststroke depression: a preliminary study. Biol Psychiatry 55: 398-405.
61. Mosimann UP, Schmitt W, Greenberg BD, Kosel M, Muri RM, et al. (2004) Repetitive transcranial magnetic stimulation: a putative add-on treatment for major depression in elderly patients. Psychiatry Res 126: 123-133.
62. Hausmann A, Kemmler G, Walpoth M, Mechtcheriakov S, Kramer-Reinstadler K, et al. (2004) No benefit derived from repetitive transcranial magnetic stimulation in depression: a prospective, single centre, randomised, double blind, sham controlled "add on" trial. J Neurol Neurosurg Psychiatry 75: 320-322.
63. Rossini D, Magri L, Lucca A, Giordani S, Smeraldi E, et al. (2005) Does rTMS hasten the response to escitalopram, sertraline, or venlafaxine in patients with major depressive disorder? A double-blind, randomized, sham-controlled trial. J Clin Psychiatry 66: 1569-1575.
64. Rumi DO, Gattaz WF, Rigonatti SP, Rosa MA, Fregni F, et al. (2005) Transcranial magnetic stimulation accelerates the antidepressant effect of amitriptyline in severe depression: a double-blind placebo-controlled study. Biol Psychiatry 57: 162-166.
65. Su TP, Huang CC, Wei IH (2005) Add-on rTMS for medication-resistant depression: a randomized, double-blind, sham-controlled trial in Chinese patients. J Clin Psychiatry 66: 930-937.
66. Januel D, Dumortier G, Verdon CM, Stamatiadis L, Saba G, et al. (2006) A double-blind sham controlled study of right prefrontal repetitive transcranial magnetic stimulation (rTMS): therapeutic and cognitive effect in medication free unipolar depression during 4 weeks. Prog Neuropsychopharmacol Biol Psychiatry 30: 126-130.
67. Avery DH, Holtzheimer PE 3rd, Fawaz W, Russo J, Neumaier J, et al. (2006) A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression. Biol Psychiatry 59: 187-194.
68. Garcia-Toro M, Salva J, Daumal J, Andres J, Romera M, et al. (2006) High (20-Hz) and low (1-Hz) frequency transcranial magnetic stimulation as adjuvant treatment in medication-resistant depression. Psychiatry Res 146: 53-57.
69. Stern WM, Tormos JM, Press DZ, Pearlman C, Pascual-Leone A (2007) Antidepressant effects of high and low frequency repetitive transcranial magnetic stimulation to the dorsolateral prefrontal cortex: a double-blind, randomized, placebo-controlled trial. J Neuropsychiatry Clin Neurosci 19: 179-186.
70. Bortolomasi M, Minelli A, Fuggetta G, Perini M, Comencini S, et al. (2007) Long-lasting effects of high frequency repetitive transcranial magnetic stimulation in major depressed patients. Psychiatry Res 150: 181-186.
71. Mogg A, Pluck G, Eranti SV, Landau S, Purvis R, et al. (2008) A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression. Psychol Med 38: 323-333.
72. Wade A, Michael Lemming O, Bang Hedegaard K (2002) Escitalopram 10 mg/ day is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol 17: 95-102.
73. Lepola UM, Loft H, Reines EH (2003) Escitalopram (10-20 mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol 18: 211-217.
74. Wagner KD, Jonas J, Findling RL, Ventura D, Saikali K (2006) A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression. J Am Acad Child Adolesc Psychiatry 45: 280-288.