Literature DB >> 19482985

A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders.

B W Dunlop1, J Banja.   

Abstract

The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, "best proven diagnostic and therapeutic method" that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings of potential for suicidality in young people treated with antidepressants, along with meta-analyses suggesting that antidepressants add no significant clinical benefit over placebos, warrant a re-evaluation of the arguments against placebo. Furthermore, the nature of placebo treatment in short-term clinical trials is often not well understood, and lack of understanding can foster opposition to it. This paper will show how scientific justifications for placebo use are morally relevant. The fundamental ethical importance of placebo controls is discussed in relation to several aspects of clinical trials, including detection of adverse events, accurate assessment of clinical benefit, advancing understanding of the heterogeneity of depression and anxiety disorders and respecting informed consent requirements. Prohibiting the use of placebo controls is morally concerning in that such prohibitions allow for the possibility of serious adverse public health consequences. Moral worries that research participants receiving placebo are being unduly jeopardised will be shown to be exaggerated, especially in relation to the net benefits for end-users to be gained from the quality of data resulting from using placebo controls.

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Year:  2009        PMID: 19482985      PMCID: PMC3711824          DOI: 10.1136/jme.2008.028357

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  25 in total

1.  The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective.

Authors:  T P Laughren
Journal:  Eur Psychiatry       Date:  2001-11       Impact factor: 5.361

Review 2.  Depression, sleep physiology, and antidepressant drugs.

Authors:  A Winokur; K A Gary; S Rodner; C Rae-Red; A T Fernando; M P Szuba
Journal:  Depress Anxiety       Date:  2001       Impact factor: 6.505

3.  The ethics of placebo-controlled trials--a middle ground.

Authors:  E J Emanuel; F G Miller
Journal:  N Engl J Med       Date:  2001-09-20       Impact factor: 91.245

4.  Understanding the divergent data on postmenopausal hormone therapy.

Authors:  Francine Grodstein; Thomas B Clarkson; JoAnn E Manson
Journal:  N Engl J Med       Date:  2003-02-13       Impact factor: 91.245

5.  What makes placebo-controlled trials unethical?

Authors:  Franklin G Miller; Howard Brody
Journal:  Am J Bioeth       Date:  2002       Impact factor: 11.229

6.  Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database.

Authors:  Arif Khan; Robyn M Leventhal; Shirin R Khan; Walter A Brown
Journal:  J Clin Psychopharmacol       Date:  2002-02       Impact factor: 3.153

7.  Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues.

Authors:  R Temple; S S Ellenberg
Journal:  Ann Intern Med       Date:  2000-09-19       Impact factor: 25.391

Review 8.  Placebo response in studies of major depression: variable, substantial, and growing.

Authors:  B Timothy Walsh; Stuart N Seidman; Robyn Sysko; Madelyn Gould
Journal:  JAMA       Date:  2002-04-10       Impact factor: 56.272

Review 9.  National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

Authors:  Dennis S Charney; Charles B Nemeroff; Lydia Lewis; Sally K Laden; Jack M Gorman; Eugene M Laska; Michael Borenstein; Charles L Bowden; Arthur Caplan; Graham J Emslie; Dwight L Evans; Barbara Geller; Lenore E Grabowski; Jay Herson; Ned H Kalin; Paul E Keck; Irving Kirsch; K Ranga R Krishnan; David J Kupfer; Robert W Makuch; Franklin G Miller; Herbert Pardes; Robert Post; Mildred M Reynolds; Laura Roberts; Jerrold F Rosenbaum; Donald L Rosenstein; David R Rubinow; A John Rush; Neal D Ryan; Gary S Sachs; Alan F Schatzberg; Susan Solomon
Journal:  Arch Gen Psychiatry       Date:  2002-03

10.  World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and post-traumatic stress disorders - first revision.

Authors:  Borwin Bandelow; Joseph Zohar; Eric Hollander; Siegfried Kasper; Hans-Jürgen Möller; Joseph Zohar; Eric Hollander; Siegfried Kasper; Hans-Jürgen Möller; Borwin Bandelow; Christer Allgulander; José Ayuso-Gutierrez; David S Baldwin; Robertas Buenvicius; Giovanni Cassano; Naomi Fineberg; Loes Gabriels; Ian Hindmarch; Hisanobu Kaiya; Donald F Klein; Malcolm Lader; Yves Lecrubier; Jean-Pierre Lépine; Michael R Liebowitz; Juan José Lopez-Ibor; Donatella Marazziti; Euripedes C Miguel; Kang Seob Oh; Maurice Preter; Rainer Rupprecht; Mitsumoto Sato; Vladan Starcevic; Dan J Stein; Michael van Ameringen; Johann Vega
Journal:  World J Biol Psychiatry       Date:  2008       Impact factor: 4.132

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  6 in total

1.  Survey of investigators' opinions on the acceptability of interactions with patients participating in clinical trials.

Authors:  Boadie W Dunlop; Christopher L Vaughan
Journal:  J Clin Psychopharmacol       Date:  2010-06       Impact factor: 3.153

2.  Enhancing informed consent in clinical trials and exploring resistances to disclosing adverse clinical trial results.

Authors:  John D Banja; Boadie Dunlop
Journal:  Am J Bioeth       Date:  2009-08       Impact factor: 11.229

3.  The investigator and the IRB: a survey of depression and schizophrenia researchers.

Authors:  Bernard A Fischer; Praveen George
Journal:  Schizophr Res       Date:  2010-01-12       Impact factor: 4.939

4.  Local IRBs vs. federal agencies: shifting dynamics, systems, and relationships.

Authors:  Robert L Klitzman
Journal:  J Empir Res Hum Res Ethics       Date:  2012-07       Impact factor: 1.742

5.  Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews.

Authors:  April V P Clyburne-Sherin; Pravheen Thurairajah; Mufiza Z Kapadia; Margaret Sampson; Winnie W Y Chan; Martin Offringa
Journal:  Trials       Date:  2015-09-18       Impact factor: 2.279

6.  Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine.

Authors:  Isaac N Kwakye; Matthew Garner; David S Baldwin; Susan Bamford; Verity Pinkney; Felicity L Bishop
Journal:  Hum Psychopharmacol       Date:  2016-07       Impact factor: 1.672

  6 in total

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