Placebo-controlled trials in psychiatric research: An ethical perspective

Biological Psychiatry

Volumn 47, Issue 8, 2000, Pages 707-716

  Miller, Franklin G ^a,b  

^a NATIONAL INSTITUTE OF MENTAL HEALTH   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Clinical trials; Ethics; Placebos; Psychiatric research

Indexed keywords

PLACEBO;

CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; ETHICS; HUMAN; INFORMED CONSENT; MENTAL DISEASE; METHODOLOGY; PRIORITY JOURNAL; PSYCHIATRY; REVIEW; RISK BENEFIT ANALYSIS; STANDARD; VOLUNTEER;

BIOMEDICAL AND BEHAVIORAL RESEARCH; MENTAL HEALTH THERAPIES;

ANTIPSYCHOTIC AGENTS; CONTROLLED CLINICAL TRIALS; ETHICS, MEDICAL; HUMANS; MENTAL DISORDERS; PLACEBOS;

EID: 0034655931     PISSN: 00063223     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0006-3223(00)00833-7     Document Type: Review

References (47)

1. Addington D. The use of placebos in clinical trials for acute schizophrenia. Can J Psychiatry. 40:1995;171-175.
2. Appelbaum P.S., Roth L.H., Lidz C.W., Benson P., Winslade W. False hopes and best data Consent to research and the therapeutic misconception . Hastings Cent Rep. 17:(2):1987;20-24.
3. Beauchamp T.L., Childress J.F. Principles of Biomedical Ethics. 4th ed. 1994;Oxford University Press, New York.
4. Berg JW, Appelbaum PS (1999): Subjects capacity to consent to neurobiological research. In: Pincus HA, Lieberman JA, Ferris S, editors. Ethics in Psychiatric Research: A Resource Manual for Human Subjects Protection. Washington, DC: American Psychiatric Association, 81-106.
5. Brennan T.A. Proposed revisions to the Declaration of Helsinki - will they weaken the ethical principles underlying human research? N Engl J Med. 341:1999;527-531.
6. Brown W.A. Predictors of placebo response in depression. Psychopharmacol Bull. 24:1988;14-17.
7. Brown W.A. Placebo as a treatment for depression. Neuropsychopharmacology. 10:1994;265-269.
8. Capron A. Ethical and human-rights issues in research on mental disorders that may affect decision-making capacity. N Engl J Med. 340:1999;1430-1434.
9. Carpenter W.T. Jr, Schooler N.R., Kane J.M. The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry. 54:1997;401-407.
10. Charney D.S., Innis R.B., Nestler E.J. New requirements for manuscripts submitted to Biological Psychiatry: Informed consent and protection of subjects. Biol Psychiatry. 46:1999;1007-1008.
11. Clark P.I., Leaverton P.E. Scientific and ethical issues in the use of placebo controls in clinical trials. Annu Rev Public Health. 15:1994;19-38.
12. Code of Federal Regulations, 21CFR314.126 (1985).
13. Code of Federal Regulations, 45CFR46 (1991).
14. Elliot C. Caring about risks Are severely depressed patients competent to consent to research? Arch Gen Psychiatry. 54:1997;113-116.
15. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 317:1987;141-145.
16. Freedman B., Glass K.C., Weijer C. Placebo orthodoxy in clinical research. II Ethical, legal, and regulatory myths . J Law Med Ethics. 24:1996;252-259.
17. Greenberg RP, Fisher S (1997): Mood-mending medicines: Probing drug, psychotherapy, and placebo solutions. In: Fisher S, Greenberg RP, editors. From Placebo to Panacea: Putting Psychiatric Drugs to the Test. New York: Wiley, 115-172.
18. Hilts PJ (1998, May 19): Scientists and their subjects debate psychiatric research. New York Times, F1.
19. Hirschfeld R.M.A. Placebo response in the treatment of panic disorder. Bull Menninger Clin. 60:(suppl A):1996;A76-A86.
20. Kong D (1999, March 29): Use of placebos on mental patients questioned. Boston Globe.
21. Lasagna L. The Helsinki Declaration Timeless guide or irrelevant anachronism? J Clin Psychopharmacol. 15:1995;96-98.
22. Leber P. The placebo control in clinical trials (a view from the FDA). Psychopharmacol Bull. 22:1986;30-32.
23. Levine R.J. Ethics and Regulation of Clinical Research. 2nd ed. 1986;Yale University Press, New Haven, CT.
24. Levine R.J. The need to revise the Declaration of Helsinki. N Engl J Med. 341:1999;531-534.
25. Lieberman J.A. Ethical dilemmas in clinical research with human subjects An investigator's perspective . Psychopharmacol Bull. 32:1996;19-25.
26. Lieberman JA, Stroup S, Laska E, Volavka J, Gelenber A, Rush AJ, et al (1999): Issues in clinical research design: Principles, practices, and controversies. In: Pincus HA, Lieberman JA, Ferris S, editors. Ethics in Psychiatric Research: A Resource Manual for Human Subjects Protection. Washington, DC: American Psychiatric Association, 23-60.
27. Makuch R.W., Johnson M.F. Dilemmas in the use of active control groups in clinical research. IRB. 11:1989;1-5.
28. Mann J., Goodwin F.K., O'Brien C.P., Robinsion D.S. Suicidal behavior and psychotropic medication. Neuropsychopharmacology. 8:1993;177-183.
29. Miller F.G., Pickar D., Rosenstein D.L. Addressing ethical issues in the psychiatric research literature. Arch Gen Psychiatry. 56:1999;763-764.
30. Miller F.G., Rosenstein D.L. Independent capacity assessment A critique . BioLaw. 11:1999;S432-S439.
31. Miller F.G., Rosenstein D.L., DeRenzo E.G. Professional integrity in clinical research. JAMA. 280:1998;1449-1454.
32. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, Vol 1, Report and Recommendations. 1998;National Bioethics Advisory Commission, Rockville, MD.
33. The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research . 1978;Department of Health, Education, and Welfare, Washington, DC.
34. Protecting Human Research Subjects Institutional Review Board Guidebook . 1993;U.S. Government Printing Office, Washington, DC.
35. Prien R.F. Methods and models for placebo use in pharmacotherapeutic trials. Psychopharmacol Bull. 24:1988;4-8.
36. Quitkin F.M. Placebos, drug effects, and study design A clinician's guide . Am J Psychiatry. 156:1999;829-836.
37. Rickels K. Use of placebo in clinical trials. Psychopharmacol Bull. 2:1986;19-24.
38. Rothman K.J., Michels K.B. The continuing unethical use of placebo controls. N Engl J Med. 331:1994;394-398.
39. Shapiro A.K., Shapiro E. The Powerful Placebo. 1997;Johns Hopkins University Press, Baltimore.
40. Streiner D.L. Placebo-controlled trials When are they needed? Schizophr Res. 35:1999;201-210.
41. Taubes G. Use of placebo controls in clinical trials disputed. Science. 267:1995;25-26.
42. Temple R. Problems in interpreting active control equivalence trials. Shamoo A.E. Ethics in Neurobiological Research with Human Subjects The Baltimore Conference on Ethics . 1997;Gordon and Breach, Amsterdam.
43. United States Food and Drug Administration (1989): Supplementary advisory: Placebo-controlled and active controlled drug study designs. In: Brody B, editor. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 291-292.
44. Weijer C. Placebo-controlled trials in schizophrenia Are they ethical? Are they necessary? Schizophr Res. 35:1999;211-218.
45. Whitaker R, Kong D (1998, November 15): Testing takes a human toll. Boston Globe, A1.
46. World Medical Association (1996): Declaration of Helsinki. In: Brody B, editor. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 214-216.
47. Zipursky R.B., Darby P. Placebo-controlled studies in schizophrenia - ethical and scientific perspectives An overview of conference proceedings . Schizophr Res. 35:1999;189-200.