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Teens and Research

Should We Enroll Adolescents in Trials of Deep Brain Stimulation for Anorexia Nervosa?

Published online by Cambridge University Press:  16 September 2016

CAROLYN PLUNKETT NEUHAUS
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Abstract:

On seeing promising results in a small number of patients, some researchers are conducting trials to determine whether deep brain stimulation (DBS) is an effective treatment for anorexia nervosa (AN). This article asks whether we should open enrollment in trials of DBS for AN to adolescents. Despite concerns about informed consent, parental consent, and unforeseeable psychological sequelae, the article concludes that the risks to anorexic adolescents associated with participation in trials of DBS are reasonable considering the substantial risks of not enrolling teens with AN in research on DBS. The seriousness of AN, its high incidence in teens, and serious shortfalls in the AN treatment literature point to the need for improved, evidence-based treatments for teens with AN. This unmet need generates an obligation on the part of researchers and physicians to promote and conduct research on AN in adolescents.

Keywords

deep brain stimulationanorexia nervosaadolescentsinformed consentparental consentresearch ethics
Type
Articles
Information
Cambridge Quarterly of Healthcare Ethics , Volume 25 , Special Issue 4: Clinical Neuroethics , October 2016 , pp. 659 - 673
Copyright
Copyright © Cambridge University Press 2016 

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References

Notes

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric; 2013.Google ScholarPubMed

2. Touyz, S, Le Grange, D, Lacey, H, Hay, P, Smith, R, Maguire, S, et al. Treating severe and enduring anorexia nervosa: A randomized controlled trial. Psychological Medicine 2013 Dec;43(12):2501–11.CrossRefGoogle ScholarPubMed

3. Swanson, SA, Crow, SJ, Le Grange, D, Swendsen, J, Merikangas, KR. Prevalence and correlates of eating disorders in adolescents: Results from the national comorbidity survey replication adolescent supplement. Archives of General Psychiatry 2011 July;68(7):714–23.CrossRefGoogle ScholarPubMed

4. Smink, FRE, van Hoeken, D, Hoek, HW. Epidemiology of eating disorders: Incidence, prevalence and mortality rates. Current Psychiatry Reports 2012 Aug;14(4):406–14.CrossRefGoogle ScholarPubMed

5. See note 4, Smink et al. 2012.

6. Van Son, GE, van Hoeken, D, Bartelds, AIM, van Furth, EF, Hoek, HW. Time trends in the incidence of eating disorders: A primary care study in the Netherlands. The International Journal of Eating Disorders 2006 Nov;39(7):565–9.CrossRefGoogle ScholarPubMed

7. Favaro, A, Caregaro, L, Tenconi, E, Bosello, R, Santonastaso, P. Time trends in age at onset of anorexia nervosa and bulimia nervosa. Journal of Clinical Psychiatry 2009 Dec;70(12):1715–21.CrossRefGoogle ScholarPubMed

8. Weaver, L, Sit, L, Liebman, R. Treatment of anorexia nervosa in children and adolescents. Current Psychiatry Reports 2012 Apr;14(2):96–100.CrossRefGoogle ScholarPubMed

9. See note 4, Smink et al. 2012.

10. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Mental Health Findings. HHS Publication No. (SMA) 14-4887. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014; available at http://www.samhsa.gov/data/sites/default/files/NSDUHmhfr2013/NSDUHmhfr2013.pdf (last accessed 15 Jan 2016).

11. Hudson, JI, Hiripi, E, Pope, HG, Kessler, RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biological Psychiatry 2007 Feb 1;61(3):348–58.CrossRefGoogle ScholarPubMed

12. Bulik, CM. Eating disorders in adolescents and young adults. Child and Adolescent Psychiatric Clinics of North America 2002 Apr;11(2):201–18.CrossRefGoogle ScholarPubMed

13. Powers, PS, Santana, CA. Childhood and adolescent anorexia nervosa. Child and Adolescent Psychiatric Clinics of North America 2002 Apr;11(2):219–35.CrossRefGoogle ScholarPubMed

14. Campbell, K, Peebles, R. Eating disorders in children and adolescents: State of the art review. Pediatrics 2014 Sept;134(3):582–92.CrossRefGoogle ScholarPubMed

15. Harris, EC, Barraclough, B. Excess mortality of mental disorder. British Journal of Psychiatry 1998 July;173:11–53.CrossRefGoogle ScholarPubMed

16. Arcelus, J, Mitchell, AJ, Wales, J, Nielsen, S. Mortality rates in patients with anorexia nervosa and other eating disorders: A meta-analysis of 36 studies. Archives of General Psychiatry 2011 July;68(7):724–31.CrossRefGoogle ScholarPubMed

17. Sullivan, PF. Mortality in anorexia nervosa. American Journal of Psychiatry 1995 July;152(7):1073–4.Google ScholarPubMed

18. Steinhausen, H-C. The outcome of anorexia nervosa in the 20th century. American Journal of Psychiatry 2002 Aug;159(8):1284–93.CrossRefGoogle ScholarPubMed

19. Keel, PK, Brown, TA. Update on course and outcome in eating disorders. International Journal of Eating Disorders 2010 Apr;43(3):195–204.Google ScholarPubMed

20. Steinhausen, H-C, Grigoroiu-Serbanescu, M, Boyadjieva, S, Neumärker, K-J, Winkler Metzke, C. Course and predictors of rehospitalization in adolescent anorexia nervosa in a multisite study. International Journal of Eating Disorders 2008 Jan;41(1):29–36.CrossRefGoogle Scholar

21. Bryant-Waugh, R, Knibbs, J, Fosson, A, Kaminski, Z, Lask, B. Long term follow up of patients with early onset anorexia nervosa. Archives of Disease in Childhood 1988 Jan;63(1):5–9.CrossRefGoogle ScholarPubMed

22. Wentz, E, Gillberg, IC, Anckarsäter, H, Gillberg, C, Råstam, M. Adolescent-onset anorexia nervosa: 18-year outcome. British Journal of Psychiatry 2009 Feb;194(2):168–74.CrossRefGoogle ScholarPubMed

23. Strober, M. Managing the chronic, treatment-resistant patient with anorexia nervosa. International Journal of Eating Disorders 2004 Nov;36(3):245–55.CrossRefGoogle ScholarPubMed

24. Wonderlich, S, Mitchell, JE, Crosby, RD, Myers, TC, Kadlec, K, Lahaise, K, et al. Minimizing and treating chronicity in the eating disorders: A clinical overview. International Journal of Eating Disorders 2012 May;45(4):467–75.CrossRefGoogle ScholarPubMed

25. See note 23, Strober 2004.

26. See note 24, Wonderlich et al. 2012.

27. Bulik, CM, Berkman, ND, Brownley, KA, Sedway, JA, Lohr, KN. Anorexia nervosa treatment: A systematic review of randomized controlled trials. International Journal of Eating Disorders 2007 May;40(4):310–20.CrossRefGoogle ScholarPubMed

28. Norrington, A, Stanley, R, Tremlett, M, Birrell, G. Medical management of acute severe anorexia nervosa. Archives of Disease in Childhood—Education and Practice Edition 2012 Apr;97(2):48–54.CrossRefGoogle ScholarPubMed

29. See note 2, Touyz et al. 2013.

30. See note 24, Wonderlich et al. 2012.

31. Bamford, BH, Mountford, VA. Cognitive behavioural therapy for individuals with longstanding anorexia nervosa: Adaptations, clinician survival and system issues. European Eating Disorders Review 2012 Jan;20(1):49–59.CrossRefGoogle ScholarPubMed

32. Rhodes, R. A placebo controlled trial for an NMO relapse prevention treatment: Ethical considerations. Multiple Sclerosis and Related Disorders 2015 Nov;4(6):580–4.CrossRefGoogle ScholarPubMed

33. Welch, MJ, Lally, R, Miller, JE, Pittman, S, Brodsky, L, Caplan, AL, et al. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials 2015 Oct;12(5):503–10.CrossRefGoogle ScholarPubMed

34. See note 13, Powers, Santana 2002.

35. See note 14, Campbell, Peebles 2014.

36. Tillman D-B. Approval order Medtronic Reclaim® deep brain stimulation for obsessive compulsive disorder (OCD) therapy; 2009; available at http://www.accessdata.fda.gov/cdrh_docs/pdf5/H050003a.pdf (last accessed 1 Dec 2015).

37. Schultz D. Approval order Medtronic Activa® dystonia therapy; 2003; available at http://www.accessdata.fda.gov/cdrh_docs/pdf2/H020007a.pdf (last accessed 10 Mar 2016).

38. Costello AH. Medtronic Activa® dystonia therapy humanitarian device exemption (HDS) H020007. Meeting of the FDA Pediatric Advisory Committee; 2014 Apr 21; available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM387697.pdf (last accessed 10 Mar 2016).

39. Walcott, BP, Nahed, BV, Kahle, KT, Duhaime, A-C, Sharma, N, Eskandar, EN. Deep brain stimulation for medically refractory life-threatening status dystonicus in children. Journal of Neurosurgery—Pediatrics 2012 Jan;9(1):99–102.CrossRefGoogle ScholarPubMed

40. See note 36, Costello 2014.

41. Smith KM, Spindler MA. Uncommon applications of deep brain stimulation in hyperkinetic movement disorders. Tremor and Other Hyperkinetic Movements 2015 Feb 2.

42. Motlagh MG, Smith ME, Landeros-Weisenberger A, Kobets AJ, King RA, Miravite J, et al. Lessons learned from open-label deep brain stimulation for Tourette syndrome: Eight cases over 7 years. Tremor and Other Hyperkinetic Movements 2013 Nov 1.

43. Huasen, B, McCreary, R, Evans, J, Potter, G, Silverdale, M. Cervical myelopathy secondary to Tourette’s syndrome managed by urgent deep brain stimulation. Movement Disorders 2014 Apr;29(4):452–3.CrossRefGoogle ScholarPubMed

44. See note 41, Smith, Spindler 2015.

45. Oudijn, MS, Storosum, JG, Nelis, E, Denys, D. Is deep brain stimulation a treatment option for anorexia nervosa? BMC Psychiatry 2013;13:277.CrossRefGoogle ScholarPubMed

46. Park, RJ, Godier, LR, Cowdrey, FA. Hungry for reward: How can neuroscience inform the development of treatment for anorexia nervosa? Behaviour Research and Therapy 2014 Nov;62:47–59.CrossRefGoogle ScholarPubMed

47. See note 46, Park et al. 2014.

48. See note 45, Oudijn et al. 2013.

49. Foerde, K, Steinglass, JE, Shohamy, D, Walsh, BT. Neural mechanisms supporting maladaptive food choices in anorexia nervosa. Nature Neuroscience 2015 Nov;18(11):1571–3.CrossRefGoogle ScholarPubMed

50. Israël, M, Steiger, H, Kolivakis, T, McGregor, L, Sadikot, AF. Deep brain stimulation in the subgenual cingulate cortex for an intractable eating disorder. Biological Psychiatry 2010 May 1;67(9):e53–4.CrossRefGoogle ScholarPubMed

51. McLaughlin, NCR, Didie, ER, Machado, AG, Haber, SN, Eskandar, EN, Greenberg, BD. Improvements in anorexia symptoms after deep brain stimulation for intractable obsessive-compulsive disorder. Biological Psychiatry 2013 May 1;73(9):e29–31.CrossRefGoogle ScholarPubMed

52. Wang, J, Chang, C, Geng, N, Wang, X, Gao, G. Treatment of intractable anorexia nervosa with inactivation of the nucleus accumbens using stereotactic surgery. Stereotactic and Functional Neurosurgery 2013;91(6):364–72.CrossRefGoogle ScholarPubMed

53. Wu, H, Van Dyck-Lippens, PJ, Santegoeds, R, van Kuyck, K, Gabriëls, L, Lin, G, et al. Deep-brain stimulation for anorexia nervosa. World Neurosurgery 2013 Oct;80(3–4):S29.e1–10.CrossRefGoogle ScholarPubMed

54. De Zwaan, M, Schlaepfer, TE. Not too much reason for excitement: Deep brain stimulation for anorexia nervosa. European Eating Disorders Review 2013 Nov;21(6):509–11.CrossRefGoogle ScholarPubMed

55. Lipsman, N, Woodside, DB, Giacobbe, P, Hamani, C, Carter, JC, Norwood, SJ, et al. Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: A Phase 1 pilot trial. Lancet 2013 Apr 20;381(9875):1361–70.CrossRefGoogle ScholarPubMed

56. Pouratian, N, Thakkar, S, Kim, W, Bronstein, JM. Deep brain stimulation for the treatment of Parkinson’s disease: Efficacy and safety. Degenerative Neurological and Neuromuscular Disease 2012 Sept 4;2012(2).Google ScholarPubMed

57. See note 54, De Zwaan, Schlaepfer 2013.

58. Seller, CA, Ravalia, A. Anaesthetic implications of anorexia nervosa. Anaesthesia 2003 May;58(5):437–43.CrossRefGoogle ScholarPubMed

59. Lipsman, N, Glannon, W. Brain, mind and machine: What are the implications of deep brain stimulation for perceptions of personal identity, agency and free will? Bioethics 2013 Nov 1;27(9):465–70.CrossRefGoogle ScholarPubMed

60. Kraemer, F. Me, myself and my brain implant: Deep brain stimulation raises questions of personal authenticity and alienation. Neuroethics 2013;6(3):483–97.CrossRefGoogle ScholarPubMed

61. Synofzik, M, Schlaepfer, TE. Stimulating personality: Ethical criteria for deep brain stimulation in psychiatric patients and for enhancement purposes. Biotechnology Journal 2008 Dec;3(12):1511–20.CrossRefGoogle ScholarPubMed

62. Baylis, F. “I am who I am”: On the perceived threats to personal identity from deep brain stimulation. Neuroethics 2013;6:513–26.CrossRefGoogle ScholarPubMed

63. See note 32, Rhodes 2015.

64. U.S. Department of Health and Human Services. Code of Federal Regulations. Title 45, Part 46; available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (last accessed 10 Mar 2016).

65. Rabins, P, Appleby, BS, Brandt, J, DeLong, MR, Dunn, LB, Gabriëls, L, et al. Scientific and ethical issues related to deep brain stimulation for disorders of mood, behavior, and thought. Archives of General Psychiatry 2009 Sept;66(9):931–7.CrossRefGoogle ScholarPubMed

66. Grant, RA, Halpern, CH, Baltuch, GH, O’Reardon, JP, Caplan, A. Ethical considerations in deep brain stimulation for psychiatric illness. Journal of Clinical Neuroscience 2014 Jan;21(1):1–5.CrossRefGoogle ScholarPubMed

67. Institute of Medicine (US) Committee on Clinical Research Involving Children. Ethical Conduct of Clinical Research Involving Children. Field MJ, Behrman RE, eds. Washington, DC: National Academies Press (US); 2004; available at http://www.ncbi.nlm.nih.gov/books/NBK25557/ (last accessed 10 Mar 2016).

68. Grant, RA, Halpern, CH, Baltuch, GH, O’Reardon, JP, Caplan, A. Ethical considerations in deep brain stimulation for psychiatric illness. Journal of Clinical Neuroscience 2014 Jan;21(1):1–5, at 2.CrossRefGoogle ScholarPubMed

69. Hindmarch, T, Hotopf, M, Owen, GS. Depression and decision-making capacity for treatment or research: A systematic review. BMC Medical Ethics 2013;14:54.CrossRefGoogle ScholarPubMed

70. Owen, GS, Szmukler, G, Richardson, G, David, AS, Raymont, V, Freyenhagen, F, et al. Decision-making capacity for treatment in psychiatric and medical in-patients: Cross-sectional, comparative study. British Journal of Psychiatry 2013 Dec;203(6):461–7.CrossRefGoogle ScholarPubMed

71. Tan, DJ, Hope, PT, Stewart, DA, Fitzpatrick, PR. Competence to make treatment decisions in anorexia nervosa: Thinking processes and values. Philosophy, Psychiatry & Psychology 2006 Dec;13(4):267–82.CrossRefGoogle ScholarPubMed

72. Gans, M, Gunn, W. End-stage anorexia: Criteria for competence to refuse treatment. In: Sisti, D, Caplan, AL, Rimon-Greenspan, H, eds. Applied Ethics in Mental Health Care: An Interdisciplinary Reader. Cambridge, MA: MIT Press; 2013:91–114.CrossRefGoogle Scholar

73. Hope, T, Tan, J, Stewart, A, McMillan, J. Agency, ambivalence and authenticity: The many ways in which anorexia nervosa can affect autonomy. International Journal of Law in Context 2013 Mar;9(special issue 01):20–36.CrossRefGoogle Scholar

74. See note 73, Hope et al. 2013, at 30.

75. See note 73, Hope et al. 2013, at 31.

76. See note 73, Hope et al. 2013, at 31.

77. Hope, T, Tan, J, Stewart, A, Fitzpatrick, R. Anorexia nervosa and the language of authenticity. The Hastings Center Report 2011 Dec;41(6):19–29, at 26.CrossRefGoogle ScholarPubMed

78. See note 73, Hope et al. 2013.

79. Craigie, J. Competence, practical rationality and what a patient values. Bioethics 2011 July;25(6):326–33.CrossRefGoogle ScholarPubMed

80. See note 64, U.S. Department of Health and Human Services.

81. Hay, PJ, Touyz, S, Sud, R. Treatment for severe and enduring anorexia nervosa: A review. Australian and New Zealand Journal of Psychiatry 2012 Dec;46(12):1136–44.CrossRefGoogle ScholarPubMed

82. See note 2, Touyz et al. 2013.