Consideraciones bioéticas, legales y clínicas en el uso terapéutico de la psilocibina para trastornos depresivos

Autores/as

DOI:

https://doi.org/10.1344/rbd2025.65.49541

Palabras clave:

Psilocibina, Psilocybe, Psicodélicos, Depresión, Bioética, Ética biomédica, Derecho médico

Resumen

La psilocibina ha emergido como un posible tratamiento alternativo para los trastornos depresivos y los casos resistentes a terapias con psicofármacos convencionales. Ensayos clínicos han reportado mejorías significativas en la severidad de los síntomas depresivos, con un perfil de seguridad relativamente favorable bajo supervisión médica y acompañamiento terapéutico. No obstante, la complejidad de su mecanismo de acción —caracterizado por efectos psicodélicos, reorganización de redes cerebrales y potenciales cambios profundos en la experiencia subjetiva— plantea importantes retos legales y de ética biomédica. Aspectos como la necesidad de un consentimiento informado robusto, la vulnerabilidad de los pacientes ante experiencias, alucinaciones, o disolución del ego, y la supervisión rigurosa de los profesionales de la salud, resultan centrales para garantizar el respeto de los derechos de los pacientes. Por otro lado, la actual legislación en países como Colombia y España limita el uso de la psilocibina al ámbito investigativo bajo excepcionales requisitos, imponiendo barreras a su aplicación clínica y terapéutica. Este artículo integra hallazgos sobre la eficacia y la seguridad de la psilocibina para trastornos depresivos con las consideraciones bioéticas y legales asociadas, señalando la importancia de protocolos cuidadosamente diseñados, la formación especializada de los terapeutas y la adaptación de la normativa, para aprovechar de modo responsable el notable potencial terapéutico de esta sustancia.

Biografía del autor/a

Diego Borbón, Universidad Externado de Colombia, Facultad de Derecho; Universität Zürich, Institut für Biomedizinische Ethik und Medizingeschichte

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. 

Citas

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).

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Publicado

2025-10-21

Cómo citar

Borbón, D. (2025). Consideraciones bioéticas, legales y clínicas en el uso terapéutico de la psilocibina para trastornos depresivos. Revista De Bioética Y Derecho, (65), 32–54. https://doi.org/10.1344/rbd2025.65.49541

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