Participants' Perceptions of Deep Brain Stimulation Research for Treatment-Resistant Depression: Risks, Benefits, and Therapeutic Misconception

AJOB Primary Research

Volumn 2, Issue 4, 2011, Pages 33-41

  Leykin, Yan ^a   Christopher, Paul ^b   Holtzheimer, Paul ^c   Appelbaum, Paul ^d   Mayberg, Helen ^c   Lisanby, Sarah ^e   Dunn, Laura ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^c EMORY UNIVERSITY   (United States)

^d Och Spine at New York Presbyterian Hospitals   (United States)

^e DUKE UNIVERSITY   (United States)

Author keywords

informed consent; major depression; research benefits; research risks; therapeutic misconception

Indexed keywords

EID: 84859395989     PISSN: 21507716     EISSN: 21507724     Source Type: Journal    
DOI: 10.1080/21507716.2011.627579     Document Type: Article

References (55)

1. Appelbaum, P. S. and Grisso, T. 2001. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research, Sarasota, FL: Professional Resource Press.
2. Appelbaum, P. S., Lidz, C. W. and Grisso, T. 2004. Therapeutic misconception in clinical research: Frequency and risk factors. IRB, 26(2): 1-8.
3. Appelbaum, P. S., Roth, L. H. and Lidz, C. 1982. The therapeutic misconception: informed consent in psychiatric research. International Journal of Law and Psychiatry, 5(3-4): 319-329.
4. Appelbaum, P. S., Roth, L. H., Lidz, C. W., Benson, P. and Winslade, W. 1987. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report, 17(2): 20-24.
5. Bell, E., Mathieu, G. and Racine, E. 2009. Preparing the ethical future of deep brain stimulation. Surgical Neurology, 72(6): 577-586.
6. Bewernick, B. H., Hurlemann, R.Matusch, A. 2010. Nucleus accumbens deep brain stimulation decreases ratings of depression and anxiety in treatment-resistant depression. Biological Psychiatry, 67(2): 110-116.
7. Charuvastra, A. and Marder, S. R. 2008. Unconscious emotional reasoning and the therapeutic misconception. Journal of Medical Ethics, 34(3): 193-197.
8. Christopher, P. P., Leykin, Y. and Holtzheimer, P. E. In press. Enrolling in deep brain stimulation research for depression: Influences on potential subjects' decision making. Depression and Anxiety,
9. Churchill, L. R., Collins, M. L., King, N. M., Pemberton, S. G. and Wailoo, K. A. 1998. Genetic research as therapy: Implications of "gene therapy" for informed consent. Journal of Law, Medicine & Ethics, 26(1): 38-47. 3
10. Daugherty, C., Ratain, M. J.Grochowski, E. 1995. Perceptions of cancer patients and their physicians involved in phase I trials. Journal of Clinical Oncology, 13(5): 1062-1072.
11. Daugherty, C. K., Banik, D. M., Janish, L. and Ratain, M. J. 2000. Quantitative analysis of ethical issues in phase I trials: A survey interview of 144 advanced cancer patients. IRB, 22(3): 6-14.
12. Dunn, L. B., Candilis, P. J. and Roberts, L. W. 2006. Emerging empirical evidence on the ethics of schizophrenia research. Schizophrenia Bulletin, 32(1): 47-68.
13. Dunn, L. B., Holtzheimer, P. E. 3rd, Hoop, J. G., Mayberg, H., Roberts, L. W. and Appelbaum, P. S. 2011. Ethical issues in deep brain stimulation research for treatment-resistant depression: Focus on risk and consent. AJOB Neuroscience, 2: 29-36.
14. Dunn, L. B., Palmer, B. W., Keehan, M., Jeste, D. V. and Appelbaum, P. S. 2006. Assessment of therapeutic misconception in older schizophrenia patients with a brief instrument. American Journal of Psychiatry, 163(3): 500-506.
15. Durand-Zaleski, I. S., Alberti, C.Durieux, P. 2008. Informed consent in clinical research in France: Assessment and factors associated with therapeutic misconception. Journal of Medical Ethics, 34(9): e16
16. Fava, M. 2003. Diagnosis and definition of treatment-resistant depression. Biological Psychiatry, 53(8): 649-659.
17. Fins, J. J., Mayberg, H. S.Nuttin, B. 2011. Misuse of the FDA's humanitarian device exemption in deep brain stimulation for obsessive-compulsive disorder. Health Affairs, 30(2): 302-311.
18. Fins, J. J. and Schiff, N. D. 2010. Conflicts of interest in deep brain stimulation research and the ethics of transparency. Journal of Clinical Ethics, 21(2): 125-132.
19. Flaherty, A. W., Williams, Z. M.Amirnovin, R. 2005. Deep brain stimulation of the anterior internal capsule for the treatment of Tourette syndrome: Technical case report. Neurosurgery, 57(4 SUPPL.): E403 discussion E403
20. Glannon, W. 2010. Consent to deep brain stimulation for neurological and psychiatric disorders. Journal of Clinical Ethics, 21(2): 104-111.
21. Goodman, W. K., Foote, K. D.Greenberg, B. D. 2010. Deep brain stimulation for intractable obsessive compulsive disorder: Pilot study using a blinded, staggered-onset design. Biological Psychiatry, 67(6): 535-542.
22. Greden, J. F. 2001. The burden of recurrent depression: Causes, consequences, and future prospects. Journal of Clinical Psychiatry, 62(SUPPL. 22): 5-9.
23. Greenberg, B. D., Malone, D. A.Friehs, G. M. 2006. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology, 31(11): 2384-2393.
24. Hamilton, M. 1960. A rating scale for depression. Journal of Neurology, Neurosurgery & Psychiatry, 23: 56-62.
25. Henderson, G. E., Churchill, L. R.Davis, A. M. 2007. Clinical trials and medical care: Defining the therapeutic misconception. PLoS Medicine, 4(11): 1735-1738.
26. Henderson, G. E., Easter, M. M.Zimmer, C. 2006. Therapeutic misconception in early phase gene transfer trials. Social Science & Medicine, 62(1): 239-253.
27. Holtzheimer, P. E. and Mayberg, H. S. 2011. Deep brain stimulation for psychiatric disorders. Annual Review of Neuroscience, 34: 289-307.
28. Jansen, L. A. 2006. The problem with optimism in clinical trials. IRB, 28(4): 13-19.
29. Jansen, L. A., Appelbaum, P. S.Klein, W. M. 2011. Unrealistic optimism in early-phase oncology trials. IRB, 33(1): 1-8.
30. Kennedy, S. H., Giacobbe, P.Rizvi, S. J. 2011. Deep brain stimulation for treatment-resistant depression: Follow-up after 3 to 6 years. American Journal of Psychiatry, 168(5): 502-510.
31. Kim, S. Y. H., Kim, H. M., McCallum, C. and Tariot, P. N. 2005. What do people at risk for Alzheimer disease think about surrogate consent for research?. Neurology, 65: 1395-1401.
32. Lidz, C. W. and Appelbaum, P. S. 2002. The therapeutic misconception: Problems and solutions. Medical Care, 40(9 SUPPL.): V55-V63.
33. Lidz, C. W., Appelbaum, P. S., Grisso, T. and Renaud, M. 2004. Therapeutic misconception and the appreciation of risks in clinical trials. Social Science & Medicine, 58(9): 1689-1697.
34. Lipsman, N., Bernstein, M. and Lozano, A. M. 2010. Criteria for the ethical conduct of psychiatric neurosurgery clinical trials. Neurosurgery Focus, 29(2): E9
35. Lozano, A. M., Mayberg, H. S., Giacobbe, P., Hamani, C., Craddock, R. C. and Kennedy, S. H. 2008. Subcallosal cingulate gyrus deep brain stimulation for treatment-resistant depression. Biological Psychiatry, 64(6): 461-467.
36. Malone, D. A. Jr., Dougherty, D. D.Rezai, A. R. 2009. Deep brain stimulation of the ventral capsule/ventral striatum for treatment-resistant depression. Biological Psychiatry, 65(4): 267-275.
37. Mayberg, H. S., Lozano, A. M.Voon, V. 2005. Deep brain stimulation for treatment-resistant depression. Neuron, 45(5): 651-660.
38. Miller, F. G. 2004. Research ethics and misguided moral intuition. Journal of Law, Medicine & Ethics, 32(1): 111-116.
39. Misra, S., Socherman, R., Hauser, P. and Ganzini, L. 2008. Appreciation of research information in patients with bipolar disorder. Bipolar Disorders, 10(5): 635-646.
40. Montgomery, S. A. and Asberg, M. 1979. A new depression scale designed to be sensitive to change. British Journal of Psychiatry, 134: 382-389.
41. Moussavi, S., Chatterji, S., Verdes, E., Tandon, A., Patel, V. and Ustun, B. 2007. Depression, chronic diseases, and decrements in health: Results from the World Health Surveys. Lancet, 370(9590): 851-858.
42. Muroff, J. R., Hoerauf, S. L. and Kim, S. Y. 2006. Is psychiatric research stigmatized? An experimental survey of the public. Schizophrenias Bulletin, 32(1): 129-136.
43. Rabins, P., Appleby, B. S.Brandt, J. 2009. Scientific and ethical issues related to deep brain stimulation for disorders of mood, behavior, and thought. Archives of General Psychiatry, 66(9): 931-937.
44. Racine, E., Waldman, S., Palmour, N., Risse, D. and Illes, J. 2007. "Currents of hope": Neurostimulation techniques in U.S. and U.K. print media. Cambridge Quarterly of Healthcare Ethics, 16(3): 312-316.
45. Roberts, L. and Roberts, B. 1999. Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness. Biological Psychiatry, 46(8): 1025-1038.
46. Roberts, L. W. 2002. Ethics and mental illness research. Psychiatric Clinics of North America, 25(3): 525-545.
47. Roberts, L. W., Hammond, K. A., Warner, T. D. and Lewis, R. 2004. Influence of ethical safeguards on research participation: Comparison of perspectives of people with schizophrenia and psychiatrists. American Journal of Psychiatry, 161(12): 2309-2311.
48. Roberts, L. W., Warner, T. D., Brody, J. L., Roberts, B., Lauriello, J. and Lyketsos, C. 2002. Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: Assessment of harm potential and factors influencing participation decisions. American Journal of Psychiatry, 159(4): 573-584.
49. Rush, A. J., Trivedi, M. H.Wisniewski, S. R. 2006. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report. American Journal of Psychiatry, 163(11): 1905-1917.
50. Schlaepfer, T. E., Lisanby, S. H. and Pallanti, S. 2010. Separating hope from hype: some ethical implications of the development of deep brain stimulation in psychiatric research and treatment. CNS Spectrums, 15(5): 285-287.
51. Synofzik, M. and Schlaepfer, T. E. 2008. Stimulating personality: Ethical criteria for deep brain stimulation in psychiatric patients and for enhancement purposes. Biotechnology Journal, 3(12): 1511-1520.
52. WHO World Mental Health Survey Consortium. 2004. Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. Journal of the American Medical Association, 291: 2581-2590.
53. Wind, J. J. and Anderson, D. E. 2008. From prefrontal leukotomy to deep brain stimulation: The historical transformation of psychosurgery and the emergence of neuroethics. Neurosurgical Focus, 25(1): E10
54. Wolpe, P. R., Ford, P. J. and Harhay, M. 2007. "Ethical issues in deep brain stimulation". In Deep brain stimulation for Parkinson's disease, Edited by: Baltuch, G. H. and Stern, M. B. 323-338. New York: Informa Healthcare.
55. World Health Organization. 2008. The global burden of disease. 2004 Update, Geneva: WHO Press.