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Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective

  • Álvaro López-Díaz (a1), Manuel Murillo-Izquierdo (a2) and Elisa Moreno-Mellado (a3)

Summary

Ketamine therapy for treatment-resistant depression in European national health systems may only be considered after attempting all evidence-based antidepressant strategies outlined in clinical guidelines. This paper seeks to explain the ethical, regulatory and procedural framework for the off-label use of ketamine for treatment-resistant depression within a public healthcare system.

Declaration of interest

None.

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Corresponding author

Correspondence: Álvaro López-Díaz, MD, UGC Salud Mental, Hospital Universitario Virgen Macarena, Avda. Dr. Fedriani, 3, 41009 Sevilla, Spain. Email: alvaro.lopez.diaz.sspa@juntadeandalucia.es

References

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1Molero, P, Ramos-Quiroga, JA, Martin-Santos, R, Calvo-Sánchez, E, Gutiérrez-Rojas, L, Meana, JJ. Antidepressant efficacy and tolerability of ketamine and esketamine: a critical review. CNS Drugs 2018; 32: 411–20.
2Royal College of Psychiatrists. Committee on ECT and Related Treatments: Statement on Ketamine to Treat Depression: Position Statement CERT02/17. Royal College of Psychiatrists, 2017 (https://www.rcpsych.ac.uk/docs/default-source/about-us/who-we-are/ectcommittee-ketamine-to-treat-depression-statement-feb17.pdf?sfvrsn=db4e7a95_2).
3Nemeroff, CB. Ketamine: Quo vadis? Am J Psychiatry 2018; 175: 297–9.
4Sanacora, G, Frye, MA, McDonald, W, Mathew, SJ, Turner, MS, Schatzberg, AF, et al. A consensus statement on the use of ketamine in the treatment of mood disorders. JAMA Psychiatry 2017; 74: 399405.
5National Institute for Health and Care Excellence. Antidepressant Treatment in Adults. National Institute for Health and Care Excellence, 2018. Available at (http://pathways.nice.org.uk/pathways/depression).
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The British Journal of Psychiatry
  • ISSN: 0007-1250
  • EISSN: 1472-1465
  • URL: /core/journals/the-british-journal-of-psychiatry
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Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective

  • Álvaro López-Díaz (a1), Manuel Murillo-Izquierdo (a2) and Elisa Moreno-Mellado (a3)
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eLetters

Ketamine – highly effective but many unanswered questions

Sebastian Moeller, University Hospital Bonn
Alexandra Philipsen, University Hospital Bonn
Helge H.O. Müller, University Hospital Bonn
16 May 2019

Sebastian Moeller1, M.D., Alexandra Philipsen1, M.D., Helge H.O. Müller1, M.D.

1Universitätsklinikum Bonn AöR, Klinik und Poliklinik für Psychiatrie, Bonn, Germany

Corresponding author:

Dr. med. Sebastian Moeller

Department of Psychiatry and Psychotherapy, Universitätsklinikum Bonn

Sigmund-Freud-Str. 25

53127 Bonn, Germany

Phone: +49-228-28731223

Fax: +49-228-28716097

Number of words: 464

Key words: Ketamine, therapy-resistant depression

No medical writer.

Conflict of interest

None declared.

Financial support

None declared.



Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective.

Álvaro López-Díaz, Manuel Murillo-Izquierdo and Elisa Moreno-Mellado

Br J Psychiatry. 2019 Apr 29:1-2. doi: 10.1192/bjp.2019.102.

We have read with great interest the Editorial “Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective.” by López-Díaz et al. (1). The authors state that subanesthetic ketamine doses rapidly induce an antidepressive effect in many patients with therapy-resistant depression (TRD) (2, 3). There might even be synergistic effects of ketamine and ECT (2). So far, there are only limited data for the duration of the antidepressant effect of ketamine (4). For prolongation of adequate outcome repeated maintenance infusions seem to be necessary. Although there are several recommendations regarding the therapeutic regimen for antidepressive maintenance i.v. therapy there is still lack of evidence for the chronological order of administration to avoid relapse (1). Furthermore, it is important to remember that more than 1/3 of patients are non-responders (3).

Common side effects of ketamine, e.g. cardiorespiratory effects, numbness, dizziness and especially dissociation make a close monitoring during infusion necessary (4). Thus, a remarkably man power for ketamine infusions for TRD-patients in a regularly clinical setting would be obligatory. Alternative routes of application are, e.g. nasal or oral ketamine (4, 5). However, similar side effects may occur (4, 5). Moreover, evidence for the chronological order of administration, especially for oral application is also low (4, 5). Another aspect that needs to be taken in account is the potentially addictive potential of ketamine (1). Thus, it remains unclear whether ketamine is a therapeutic option for depressive patients with comorbid addictive diseases.

Overall, ketamine is a very interesting and promising therapeutic option for patients with TRD. However, to implement ketamine as a standard treatment in TRD-patients in a regular clinical setting is still challenging.

Further studies are necessary to improve our understanding of the substance, the best and easiest application, the chronological order of administration and optimal handling with side effects to permit sustained benefit for patients with TRD.



Refrences

1. Lopez-Diaz A, Murillo-Izquierdo M, Moreno-Mellado E. Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective. Br J Psychiatry. 2019: 1-2.

2. Kallmunzer B, Volbers B, Karthaus A, Tektas OY, Kornhuber J, Muller HH. Treatment escalation in patients not responding to pharmacotherapy, psychotherapy, and electro-convulsive therapy: experiences from a novel regimen using intravenous S-ketamine as add-on therapy in treatment-resistant depression. J Neural Transm (Vienna). 2016; 123(5): 549-52.

3. Phillips JL, Norris S, Talbot J, Birmingham M, Hatchard T, Ortiz A, et al. Single, Repeated, and Maintenance Ketamine Infusions for Treatment-Resistant Depression: A Randomized Controlled Trial. Am J Psychiatry. 2019: appiajp201818070834.

4. Sanacora G, Frye MA, McDonald W, Mathew SJ, Turner MS, Schatzberg AF, et al. A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders. JAMA psychiatry. 2017; 74(4): 399-405.

5. Andrade C. Oral Ketamine for Depression, 1: Pharmacologic Considerations and Clinical Evidence. J Clin Psychiatry. 2019; 80(2).

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Conflict of interest: None declared

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