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

REFERENCES

• Appelbaum , P. S. and Grisso , T. 2001 . MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research , Sarasota, FL : Professional Resource Press .
   Google Scholar
• Appelbaum , P. S. , Lidz , C. W. and Grisso , T. 2004 . Therapeutic misconception in clinical research: Frequency and risk factors . IRB , 26 ( 2 ) : 1 – 8 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Bell , E. , Mathieu , G. and Racine , E. 2009 . Preparing the ethical future of deep brain stimulation . Surgical Neurology , 72 ( 6 ) : 577 – 586 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Charuvastra , A. and Marder , S. R. 2008 . Unconscious emotional reasoning and the therapeutic misconception . Journal of Medical Ethics , 34 ( 3 ) : 193 – 197 .
   PubMed Web of Science ®Google Scholar
• 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 ,
   Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Fava , M. 2003 . Diagnosis and definition of treatment-resistant depression . Biological Psychiatry , 53 ( 8 ) : 649 – 659 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• 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 .
   PubMedGoogle Scholar
• 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
   Web of Science ®Google Scholar
• Glannon , W. 2010 . Consent to deep brain stimulation for neurological and psychiatric disorders . Journal of Clinical Ethics , 21 ( 2 ) : 104 – 111 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Greden , J. F. 2001 . The burden of recurrent depression: Causes, consequences, and future prospects . Journal of Clinical Psychiatry , 62 ( suppl. 22 ) : 5 – 9 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Hamilton , M. 1960 . A rating scale for depression . Journal of Neurology, Neurosurgery & Psychiatry , 23 : 56 – 62 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• Henderson , G. E. , Easter , M. M. Zimmer , C. 2006 . Therapeutic misconception in early phase gene transfer trials . Social Science & Medicine , 62 ( 1 ) : 239 – 253 .
   PubMed Web of Science ®Google Scholar
• Holtzheimer , P. E. and Mayberg , H. S. 2011 . Deep brain stimulation for psychiatric disorders . Annual Review of Neuroscience , 34 : 289 – 307 .
   PubMed Web of Science ®Google Scholar
• Jansen , L. A. 2006 . The problem with optimism in clinical trials . IRB , 28 ( 4 ) : 13 – 19 .
   PubMedGoogle Scholar
• Jansen , L. A. , Appelbaum , P. S. Klein , W. M. 2011 . Unrealistic optimism in early-phase oncology trials . IRB , 33 ( 1 ) : 1 – 8 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Lidz , C. W. and Appelbaum , P. S. 2002 . The therapeutic misconception: Problems and solutions . Medical Care , 40 ( 9 suppl. ) : V55 – V63 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Lipsman , N. , Bernstein , M. and Lozano , A. M. 2010 . Criteria for the ethical conduct of psychiatric neurosurgery clinical trials . Neurosurgery Focus , 29 ( 2 ) : E9
   Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Mayberg , H. S. , Lozano , A. M. Voon , V. 2005 . Deep brain stimulation for treatment-resistant depression . Neuron , 45 ( 5 ) : 651 – 660 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. 2004 . Research ethics and misguided moral intuition . Journal of Law, Medicine & Ethics , 32 ( 1 ) : 111 – 116 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Montgomery , S. A. and Asberg , M. 1979 . A new depression scale designed to be sensitive to change . British Journal of Psychiatry , 134 : 382 – 389 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Roberts , L. W. 2002 . Ethics and mental illness research . Psychiatric Clinics of North America , 25 ( 3 ) : 525 – 545 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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
   Web of Science ®Google Scholar
• 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 .
   Google Scholar
• World Health Organization . 2008 . The global burden of disease. 2004 Update , Geneva : WHO Press .
   Google Scholar