Fragile promise of psychedelics in psychiatry
Open accessAbstract
Cédric Lemarchand and colleagues highlight weaknesses in the evidence on efficacy and safety of hallucinogens and question the use of expedited regulatory pathways
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Esketamine's approval is not an isolated case, as several psychedelic compounds have now been granted similar regulatory designations.
“Esketamine’s approval is not an isolated case, as several psychedelic compounds have now been granted similar regulatory designations [53].”
Cites
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression
Goodwin, G. M., Aaronson, S. T., Alvarez, O., Arden, P. C., Baker, A., Bennett, J. C., Bird, C., Blom, R. E., Brennan, C., Brusch, D., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2206443 · Cited by 1,167 · cited 1× · see citing works
“32 Cardiovascular problems are to be expected, especially in vulnerable populations, as esketamine increases the risk of hypertension.”
McIntyre, R. S., Alsuwaidan, M., Baune, B. T., Berk, M., Demyttenaere, K., Goldberg, J. F., Gorwood, P., Ho, R., Kasper, S., Kennedy, S. H., et al. (2023) · World Psychiatry · doi:10.1002/wps.21120 · Cited by 836 · see citing works
The Therapeutic Potential of Psychedelic Drugs: Past, Present, and Future
Carhart-Harris, R. L., & Goodwin, G. M. (2017) · Neuropsychopharmacology · doi:10.1038/npp.2017.84 · Cited by 706 · see citing works
Preparing for the bursting of the psychedelic hype bubble.
Yaden, D. B., Potash, J. B., & Griffiths, R. R. (2022) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2022.2546 · Cited by 162 · see citing works
Aaronson, S. T., van der Vaart, A., Miller, T., LaPratt, J., Swartz, K., Shoultz, A., Lauterbach, M., Sackeim, H. A., & Suppes, T. (2024) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2023.4685 · Cited by 114 · see citing works
US Food and Drug Administration approval of esketamine and brexanolone
Cristea, I. A., & Naudet, F. (2019) · The Lancet Psychiatry · doi:10.1016/s2215-0366(19)30292-5 · Cited by 98 · see citing works
Self-citationEsketamine for treatment resistant depression: a trick of smoke and mirrors?
Gastaldon, C., Papola, D., Ostuzzi, G., & Barbui, C. (2020) · Epidemiology and Psychiatric Sciences · doi:10.1017/s2045796019000751 · Cited by 54 · cited 1× · see citing works
“22 Functionalunblindingwasalsonot formally assessed in the first pivotal study of MDMA assisted psychotherapy used for a new drug application to the FDA.”
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Naudet, F., Pellen, C., Fodor, L. A., Gastaldon, C., Barbui, C., Turner, E. H., Le Pabic, E., & Cristea, I. A. (2025) · BMC Medicine · doi:10.1186/s12916-025-04435-x · Cited by 6 · see citing works
Self-citation
- Authors
- Lemarchand, C., Chopin, R., Paul, M., Braillon, A., Cosgrove, L., Cristea, I., Fried, E. I., Turner, E. H., & Naudet, F.
- Affiliations
- Inserm (FR)
- Amiens, France
- University of Essex (GB)
- University of Padua (IT)
- Leiden University (NL)
- Oregon Health & Science University (US)
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2024-11-19
- Volume
- 387
- Pages
- e080391
- ISSN
- 1756-1833 (ISSN-L)
- OpenAlex
- W4404517659
- Cited by
- 11
- References
- 7
- Citations by year
- 2026: 4 · 2025: 7
- FWCI
- 4.50
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by-nc)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- Agence Nationale de la Recherche (ANR-17-CE36-0010)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- psychedelics, hallucinogens, psychiatric treatment, efficacy evidence, drug safety, regulatory pathways
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