Consideracions bioètiques, legals i clíniques en l’ús terapèutic de la psilocibina per a trastorns depressius
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La psilocibina ha emergit com un possible tractament alternatiu per als trastorns depressius i els casos resistents a teràpies amb psicofàrmacs convencionals. Assajos clínics han reportat millores significatives en la severitat dels símptomes depressius, amb un perfil de seguretat relativament favorable sota supervisió mèdica i acompanyament terapèutic. No obstant això, la complexitat del seu mecanisme d'acció —caracteritzat per efectes psicodèlics, reorganització de xarxes cerebrals i potencials canvis profunds en l'experiència subjectiva— planteja importants reptes legals i d'ètica biomèdica. Aspectes com la necessitat d'un consentiment informat robust, la vulnerabilitat dels pacients davant experiències, al·lucinacions, o dissolució de l'ego, i la supervisió rigorosa dels professionals de la salut, resulten centrals per a garantir el respecte dels drets dels pacients. D'altra banda, l'actual legislació en països com Colòmbia i Espanya limita l'ús de la psilocibina a l'àmbit de la recerca sota excepcionals requisits, imposant barreres a la seva aplicació clínica i terapèutica. Aquest article integra troballes sobre l'eficàcia i la seguretat de la psilocibina per a trastorns depressius amb les consideracions bioètiques i legals associades, assenyalant la importància de protocols acuradament dissenyats, la formació especialitzada dels terapeutes i l'adaptació de la normativa, per a aprofitar de mode responsable el notable potencial terapèutic d'aquesta substància.
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(c) Diego Borbón, 2025
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Els/les autors/es conserven els drets d'autoria dels articles i autoritzen la Universitat de Barcelona a publicar-los en la seva Revista de Bioética y Derecho i a incloure'ls en els serveis d'indexació i abstracts, bases de dades acadèmiques i repositoris en els quals participa la revista. Els treballs publicats en la Revista de Bioètica i Dret estan sota la llicència Creative Commons Reconeixement-NoComercial-SenseObraDerivada 4.0 Internacional (by-nc-nd 4.0), que permet compartir l'obra amb tercers, sempre que aquests reconeguin la seva autoria, la seva publicació inicial en aquesta revista i les condicions de la llicència. No es permet un ús comercial de l'obra original ni la generació d'obres derivades.
Diego Borbón, Universidad Externado de Colombia
Docente-Investigador del Centro de Estudios sobre Genética y Derecho, y Director del Grupo de Investigación en Ciencias Biológicas y Derecho de la Universidad Externado de Colombia. Stehr-Boldt Fellow del Instituto para la Ética Biomédica y la Historia de la Medicina de la Universidad de Zúrich.
Aday, J. S., Mitzkovitz, C. M., Bloesch, E. K., Davoli, C. C., & Davis, A. K. (2020). Long-term effects of psychedelic drugs: A systematic review. Neuroscience & Biobehavioral Reviews, 113, 179–189. https://doi.org/10.1016/j.neubiorev.2020.03.017
American Psychiatric Association. (2022). Diagnostic and statistical manual of mental disorders (5th ed., text rev.). https://doi.org/10.1176/appi.books.9780890425787
American Psychiatric Association. (2022). Position statement on the use of psychedelic and empathogenic agents for mental health conditions. https://www.psychiatry.org/getattachment/d5c13619-ca1f-491f-a7a8-b7141c800904/Position-Use-of-Psychedelic-Empathogenic-Agents.pdf
Barber, G. S., & Dike, C. C. (2023). Ethical and Practical Considerations for the Use of Psychedelics in Psychiatry. Psychiatric services (Washington, D.C.), 74(8), 838–846. https://doi.org/10.1176/appi.ps.20220525
Breeksema, J. J., Niemeijer, A., Krediet, E., Karsten, T., Kamphuis, J., Vermetten, E., van den Brink, W., & Schoevers, R. (2024). Patient perspectives and experiences with psilocibin treatment for treatment-resistant depression: A qualitative study. Scientific Reports, 14, Article 2929. https://doi.org/10.1038/s41598-024-2929-5
Carhart-Harris, R., Giribaldi, B., Watts, R., Baker-Jones, M., Murphy-Beiner, A., Murphy, R., Martell, J., Blemings, A., Erritzoe, D., & Nutt, D. J. (2021). Trial of psilocibin versus escitalopram for depression. New England Journal of Medicine, 384(15), 1402–1411. https://doi.org/10.1056/NEJMoa2032994
Colorado General Assembly. (2022). Proposition 122: Natural Medicine Health Act of 2022.
Daws, R. E., Timmermann, C., Giribaldi, B., Sexton, J. D., Wall, M. B., Erritzoe, D., Roseman, L., Nutt, D., & Carhart-Harris, R. (2022). Increased global integration in the brain after psilocibin therapy for depression. Nature Medicine, 28(4), 844–851. https://doi.org/10.1038/s41591-022-01744-6.
Dodd, S., Norman, T. R., Eyre, H. A., Stahl, S. M., Phillips, A., Carvalho, A. F., & Berk, M. (2022). Psilocybin in neuropsychiatry: A review of its pharmacology, safety, and efficacy. CNS Spectrums, 28(4), 416–426. https://doi.org/10.1017/S1092852922000888
Donauer, D. (2022, 15 julio). Legal framework for the use of psychedelics in Switzerland. MLL Portal. https://www.mll-news.com/legal-framework-for-the-use-of-psychedelics-in-switzerland/
Drug Enforcement Administration. (2018, 18 de enero). DEA simplifies research registration requirements for Schedule I drugs. https://www.dea.gov/press-releases/2018/01/18/dea-speeds-application-process-research-schedule-i-drugs
Fang, S., Yang, X., & Zhang, W. (2024). Efficacy and acceptability of psilocibin for primary or secondary depression: A systematic review and meta-analysis of randomized controlled trials. Frontiers in Psychiatry, 15. https://doi.org/10.3389/fpsyt.2024.1359088
Gasser, P., Holstein, D., Michel, Y., Doblin, R., Yazar Klosinski, B., Passie, T., & Brenneisen, R. (2014). Safety and efficacy of lysergic acid diethylamide assisted psychotherapy for anxiety associated with life threatening diseases. Journal of Nervous and Mental Disease, 202(7), 513 520. https://doi.org/10.1097/NMD.0000000000000113
Glue, P., Loo, C., Fam, J., Lane, H.-Y., Young, A. H., Surman, P., et al. (2024). Extended-release ketamine tablets for treatment-resistant depression: A randomized placebo-controlled phase 2 trial. Nature Medicine, 30, 2004-2009. https://doi.org/10.1038/s41591-024-03063-x
Goodwin, G. M., Aaronson, S. T., Alvarez, O., Arden, P. C., Baker, A., Bennett, J. C., Bird, C., … & Malievskaia, E. (2022). Single-dose psilocibin for a treatment-resistant episode of major depression. New England Journal of Medicine, 387(18), 1637–1648. https://doi.org/10.1056/NEJMoa2206443
Gukasyan, N., Davis, A. K., Barrett, F. S., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., & Griffiths, R. R. (2022). Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Journal of psychopharmacology (Oxford, England), 36(2), 151–158. https://doi.org/10.1177/02698811211073759
Guss, J., Krause, R., & Slowshower, J. (2020). Yale Manual for Psilocybin-Assisted Therapy of Depression (1st ed.). https://doi.org/10.31234/osf.io/u6v9y
Haikazian, S., Chen-Li, D. C. J., Johnson, D. E., Fancy, F., Levinta, A., Husain, M. I., Mansur, R. B., McIntyre, R. S., & Rosenblat, J. D. (2023). Psilocybin-assisted therapy for depression: A systematic review and meta-analysis. Psychiatry research, 329, 115531. https://doi.org/10.1016/j.psychres.2023.115531
Heal, D. J., Smith, S. L., Belouin, S. J., & Henningfield, J. E. (2023). Psychedelics: Threshold of a therapeutic revolution. Neuropharmacology, 236, 109610. https://doi.org/10.1016/j.neuropharm.2023.109610
Holze, F., Becker, A. M., Kolaczynska, K. E., Duthaler, U., & Liechti, M. E. (2022). Pharmacokinetics and Pharmacodynamics of Oral Psilocibin Administration in Healthy Participants. Clinical Pharmacology & Therapeutics. Advance online publication. https://doi.org/10.1002/cpt.2821.
Holze, F., Gasser, P., Müller, F., Dolder, P. C., & Liechti, M. E. (2023). Lysergic acid diethylamide–assisted therapy in patients with anxiety with and without a life threatening illness: A randomized, double blind, placebo controlled phase II study. Biological Psychiatry, 93(3), 215 223. https://doi.org/10.1016/j.biopsych.2022.08.025
INVIMA. (2024). Alerta Sanitaria No. 308-2024. Instituto Nacional de Vigilancia de Medicamentos y Alimentos. https://app.invima.gov.co/alertas/ckfinder/userfiles/files/ALERTAS%20SANITARIAS/medicamentos_pbiologicos/2024/Septiembre/Alerta%20No_%20%23308-2024%20-%20%20.pdf
Johns Hopkins Medicine. (2022, 15 de febrero). Center for Psychedelic and Consciousness Research: Psilocybin treatment for major depression may be effective for up to a year.. https://www.hopkinsmedicine.org/psychiatry/research/psychedelics-research
Junta Internacional de Fiscalización de Estupefacientes. (2022). Lista de sustancias sicotrópicas sometidas a fiscalización internacional (33a edición). https://www.incb.org/documents/Psychotropics/forms/greenlist/2022/Green_List_S.pdf
Kwaśny, A., Wilkowska, A., & Cubała, W. J. (2024). Short-term safety and tolerability profile of 5-methoxy-N,N-dimethyltryptamine in human subjects: A systematic review of clinical trials. Frontiers in Psychiatry, 15, Article 1477996. https://doi.org/10.3389/fpsyt.2024.1477996
Lan, X.-J., Yang, X.-H., Mo, Y., Deng, C.-J., Huang, X.-B., Cai, D.-B., & Zheng, W. (2024). Deep transcranial magnetic stimulation for treatment-resistant depression: A systematic review and meta-analysis of randomized controlled studies. Asian Journal of Psychiatry, 96, 104032. https://doi.org/10.1016/j.ajp.2024.104032
Lowe, H., Toyang, N., Steele, B., Valentine, H., Grant, J., Ali, A., Ngwa, W., & Gordon, L. (2021). The Therapeutic Potential of Psilocibin. Molecules, 26(10), 2948. https://doi.org/10.3390/molecules26102948
McGuire, A. L., Cohen, I. G., Sisti, D., Baggott, M., Celidwen, Y., Devenot, N., … Yaden, D. B. (2024). Developing an ethics and policy framework for psychedelic clinical care: A consensus statement. JAMA Network Open, 7(6), e2414650. https://doi.org/10.1001/jamanetworkopen.2024.14650
McNamee, S., Devenot, N., & Buisson, M. (2023). Studying harms is key to improving psychedelic-assisted therapy—Participants call for changes to research landscape. JAMA Psychiatry, 80(5), 411–412. https://doi.org/10.1001/jamapsychiatry.2023.0099
Metaxa, A.-M., & Clarke, M. (2024). Efficacy of psilocibin for treating symptoms of depression: systematic review and meta-analysis. BMJ, 385, e078084. https://doi.org/10.1136/bmj-2023-078084
Nordin, M., Hlynsson, J. I., Håkansson, J., & Carlbring, P. (2024). A double-edged sword: Insights from practitioners on the short and long-term negative effects of psilocybin-assisted psychological interventions. Journal of Psychedelic Studies, 8(2), 196–203. https://doi.org/10.1556/2054.2024.00337
Oregon Health Authority. (2023). Oregon Psilocybin Services: Licensing information and resources. https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/oregon-psilocybin-services.aspx
Organización Mundial de la Salud. (2019). International Classification of Diseases 11th Revision (ICD-11). https://icd.who.int
Pilecki, B. C., Luoma, J. B., Bathje, G. J., Rhea, J., & Narloch, V. F. (2021). Ethical and legal issues in psychedelic harm reduction and integration therapy. Harm Reduction Journal, 18, 40. https://doi.org/10.1186/s12954-021-00489-1
Raison, C. L., Sanacora, G., Woolley, J., Heinzerling, K., Dunlop, B. W., Brown, R. T., Kakar, R., Hassman, M., Trivedi, R. P., Robison, R., Gukasyan, N., Nayak, S. M., Hu, X., O’Donnell, K. C., Kelmendi, B., Sloshower, J., Penn, A. D., Bradley, E., Kelly, D. F., … Griffiths, R. R. (2023). Single-Dose Psilocibin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. JAMA, 330(9), 843–853. https://doi.org/10.1001/jama.2023.14530
Ramaekers, J. G., Reckweg, J. T., & Mason, N. L. (2025). Benefits and challenges of ultra-fast, short-acting psychedelics in the treatment of depression. American Journal of Psychiatry, 182(1), 33-46. https://doi.org/10.1176/appi.ajp.20230890
Reckweg, J. T., van Leeuwen, C. J., Henquet, C., van Amelsvoort, T., Theunissen, E. L., Mason, N. L., Paci, R., Terwey, T. H., & Ramaekers, J. G. (2023). A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. Frontiers in Psychiatry, 14, Article 1133414. https://doi.org/10.3389/fpsyt.2023.1133414
Rootman, J. M., Kiraga, M., Kryskow, P., Harvey, K., Stamets, P., Santos-Brault, E., Kuypers, K. P. C., & Walsh, Z. (2022). Psilocybin microdosers demonstrate greater observed improvements in mood and mental health at one month relative to non-microdosing controls. Scientific reports, 12(1), 11091. https://doi.org/10.1038/s41598-022-14512-3
Rucker, J. J. H., Marwood, L., Ajantaival, R.-L. J., Bird, C., Barker, S. F., Bloomfield, M. A. P., ... Carhart-Harris, R. L. (2022). The effects of psilocybin on cognitive and emotional functions in healthy participants: Results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation. Journal of Psychopharmacology, 36(1), 114–125. https://doi.org/10.1177/02698811211064720
Siegel, J. S., Subramanian, S., Perry, D., Kay, B. P., Gordon, E. M., Laumann, T. O., ... Dosenbach, N. U. F. (2024). Psilocybin desynchronizes the human brain. Nature, 632(8011), 131–138. https://doi.org/10.1038/s41586-024-07624-5
Smith, W. R., & Sisti, D. (2020). Ethics and ego dissolution: The case of psilocibin. Journal of Medical Ethics. Advance online publication. https://doi.org/10.1136/medethics-2020-106070
Su, T.-P., Li, C.-T., Lin, W.-C., Wu, H.-J., Tsai, S.-J., Bai, Y.-M., et al. (2023). A randomized, double-blind, midazolam-controlled trial of low-dose ketamine infusion in patients with treatment-resistant depression and prominent suicidal ideation. International Journal of Neuropsychopharmacology, 26(5), 331-339. https://doi.org/10.1093/ijnp/pyad014
Tao, X., Jing, Z. W., Yuan, W. K., Yun, G. H., Fang, X. J., & Sheng, L. M. (2025). A meta-analysis comparing the effectiveness and safety of repetitive transcranial magnetic stimulation versus theta burst stimulation for treatment-resistant depression. Frontiers in Psychiatry, 15, 1504727. https://doi.org/10.3389/fpsyt.2024.1504727
U.S. Congress. (2023). Right to Try Clarification Act, H.R. 1825, 118th Cong.
U.S. Food and Drug Administration. (2023, junio 23). Psychedelic drugs: Considerations for clinical investigations (Draft guidance).