Antidepressants conundrums and complexities of efficacy studies

Journal of Clinical Psychopharmacology

Volumn 36, Issue 1, 2016, Pages 1-4

  Pies, Ronald W ^a,b  

^a State University of New York Upstate Medical University: College of Medicine   (United States)

^b TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT; FLUOXETINE; IMIPRAMINE; PAROXETINE; VENLAFAXINE;

DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DSM-5; DSM-IV; EDITORIAL; HAMILTON DEPRESSION RATING SCALE; HUMAN; MAJOR DEPRESSION; PRIORITY JOURNAL; QUALITY OF LIFE; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; SUICIDE ATTEMPT; CLINICAL TRIAL (TOPIC); DEPRESSIVE DISORDER, MAJOR; METHODOLOGY; PROCEDURES;

ANTIDEPRESSIVE AGENTS; CLINICAL TRIALS AS TOPIC; DEPRESSIVE DISORDER, MAJOR; HUMANS; RESEARCH DESIGN;

EID: 84952981712     PISSN: 02710749     EISSN: 1533712X     Source Type: Journal    
DOI: 10.1097/JCP.0000000000000455     Document Type: Editorial

References (34)

1. Begley S. Why antidepressants are no better than placebos. Accessed at: http://www. newsweek. com/why-antidepressants-are-no-better-placebos-71111. Accessed January 28, 2010.
2. Pies R. Are antidepressants effective in the acute and long-term treatment of depression? Sic et Non. Innov Clin Neurosci. 2012;9:31-40.
3. Vöhringer PA, Ghaemi SN. Solving the antidepressant efficacy question: effect sizes in major depressive disorder. Clin Ther. 2011;33:B49-B61.
4. Bech P. Is the antidepressive effect of second-generation antidepressants a myth? Psychol Med. 2010;40:181-186.
5. Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
6. Henry D, Fitzpatrick T. Liberating the data from clinical trials. BMJ. 2015;351:h4601.
7. Ebrahim S, Bance S, Athale A, et al. Meta-analyses with industry involvement are massively published and report no caveats for antidepressants. J Clin Epidemiol. 2015. pii: S0895-4356:00429-1. doi: 10. 1016/j. jclinepi. 2015. 08. 021. [Epub ahead of print].
8. Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358:252-260.
9. Kirsch I, Deacon BJ, Huedo-Medina TB, et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5:e45.
10. Fournier JC, DeRubeis RJ, Hollon SD, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010; 303:47-53.
11. Gibbons RD, Hur K, Brown CH, et al. 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;69:572-579.
12. Gibbons RD, Brown CH, Hur K, et al. Suicidal thoughts and behavior with antidepressant treatment: reanalysis of the randomized placebo-controlled studies of fluoxetine and venlafaxine. Arch Gen Psychiatry. 2012;69: 580-587.
13. Goldberg D. The heterogeneity of "major depression". World Psychiatry. 2011;10:226-228.
14. Preskorn SH, Macaluso M, Trivedi M. How commonly used inclusion and exclusion criteria in antidepressant registration trials affect study enrollment. J Psychiatr Pract. 2015;21:267-274.
15. Feinstein AR. Meta-analysis: statistical alchemy for the 21st century. J Clin Epidemiol. 1995;48:71-79.
16. Walsh BT, Seidman SN, Sysko R, et al. Placebo response in studies of major depression: variable, substantial, and growing. JAMA. 2002;287: 1840-1847.
17. Spielmans GI, Jureidini J, Healy D, et al. Inappropriate data and measures lead to questionable conclusions. JAMA Psychiatry. 2013;70:121-122.
18. Carroll BJ. Suicide risk and efficacy of antidepressant drugs. JAMA Psychiatry. 2013;70:123-124.
19. Stewart JA, Deliyannides DA, Hellerstein DJ, et al. Can people with nonsevere major depression benefit from antidepressant medication? J Clin Psychiatry. 2012;73:518-525.
20. Thorlund K, Druyts E, Wu P, et al. Comparative efficacy and safety of selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors in older adults: a network meta-analysis. J Am Geriatr Soc. 2015;63:1002-1009.
21. Ghaemi SN. Classic Study of the Month: The FDA analysis of antidepressants and suicide. The Psychiatry Letter. 2015. Accessed at: www. psychiatryletter. org.
22. Carroll BJ. Adolescents with depression. JAMA. 2004;292:2578.
23. Meyer RE, Salzman C, Youngstrom EA, et al. Suicidality and risk of suicide-definition, drug safety concerns, and a necessary target for drug development: a consensus statement. J Clin Psychiatry. 2010;71:e1-e21.
24. de Leon J, Baca-García E, Blasco-Fontecilla H. From the serotonin model of suicide to a mental painmodel of suicide. Psychother Psychosom. 2015;84:323-329.
25. Kobak KA, Kane JM, Thase ME, et al. Why do clinical trials fail? The problemofmeasurement error in clinical trials: time to test new paradigms? J Clin Psychopharmacol. 2007;27:1-5.
26. Bagby RM, Ryder AG, Schuller DR, et al. The Hamilton Depression Rating Scale: has the gold standard become a leadweight? AmJ Psychiatry. 2004;161:2163-2177.
27. Skevington SM, Wright A. Changes in the quality of life of patients receiving antidepressant medication in primary care: validation of the WHOQOL-100. Br J Psychiatry. 2001;178:261-267.
28. Berlim MT, Pargendler J, Brenner J, et al. Significant improvement in the quality of life of Brazilian depressed outpatients 12 weeks following the start of antidepressants. Psychiatry Res. 2007;153:253-259.
29. Regier DA, Narrow WE, Clarke DE, et al. DSM-5 field trials in the United States and Canada, part II: test-retest reliability of selected categorical diagnoses. Am J Psychiatry. 2013;170:59-70.
30. BrownW. Treatment response inmelancholia. Acta Psychiatr Scand Suppl. 2007;125-129.
31. Parker G, FinkM, Shorter E, et al. Issues for DSM-5:whithermelancholia? The case for its classification as a distinct mood disorder. Am J Psychiatry. 2010;167:745-747.
32. Preskorn S. A dangerous idea. J Prac Psych Behav Health. 1996;2: 231-234.
33. Bridge JA, Birmaher B, Iyengar S, et al. Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder. Am J Psychiatry. 2009;166:42-49.
34. Klein DF, Glick ID. Conflict of interest, journal review, and publication policy. Neuropsychopharmacology. 2008;33:3023-3026.