The therapeutic potential of psychedelics: the European regulatory perspective

Publikation: Bidrag til tidsskriftKommentar/debatForskningfagfællebedømt

Standard

The therapeutic potential of psychedelics : the European regulatory perspective. / Butlen-Ducuing, Florence; McCulloch, Drummond E.Wen; Haberkamp, Marion; Mattila, Taina; Bałkowiec-Iskra, Ewa; Aislaitner, Georgios; Balabanov, Pavel; Lundberg, Johan; Stenbæk, Dea Siggaard; Elferink, Andre; Knudsen, Gitte M.; Thirstrup, Steffen.

I: The Lancet, Bind 401, Nr. 10378, 2023, s. 714-716.

Publikation: Bidrag til tidsskriftKommentar/debatForskningfagfællebedømt

Harvard

Butlen-Ducuing, F, McCulloch, DEW, Haberkamp, M, Mattila, T, Bałkowiec-Iskra, E, Aislaitner, G, Balabanov, P, Lundberg, J, Stenbæk, DS, Elferink, A, Knudsen, GM & Thirstrup, S 2023, 'The therapeutic potential of psychedelics: the European regulatory perspective', The Lancet, bind 401, nr. 10378, s. 714-716. https://doi.org/10.1016/S0140-6736(23)00264-7

APA

Butlen-Ducuing, F., McCulloch, D. E. W., Haberkamp, M., Mattila, T., Bałkowiec-Iskra, E., Aislaitner, G., Balabanov, P., Lundberg, J., Stenbæk, D. S., Elferink, A., Knudsen, G. M., & Thirstrup, S. (2023). The therapeutic potential of psychedelics: the European regulatory perspective. The Lancet, 401(10378), 714-716. https://doi.org/10.1016/S0140-6736(23)00264-7

Vancouver

Butlen-Ducuing F, McCulloch DEW, Haberkamp M, Mattila T, Bałkowiec-Iskra E, Aislaitner G o.a. The therapeutic potential of psychedelics: the European regulatory perspective. The Lancet. 2023;401(10378):714-716. https://doi.org/10.1016/S0140-6736(23)00264-7

Author

Butlen-Ducuing, Florence ; McCulloch, Drummond E.Wen ; Haberkamp, Marion ; Mattila, Taina ; Bałkowiec-Iskra, Ewa ; Aislaitner, Georgios ; Balabanov, Pavel ; Lundberg, Johan ; Stenbæk, Dea Siggaard ; Elferink, Andre ; Knudsen, Gitte M. ; Thirstrup, Steffen. / The therapeutic potential of psychedelics : the European regulatory perspective. I: The Lancet. 2023 ; Bind 401, Nr. 10378. s. 714-716.

Bibtex

@article{9fc0dadacfa841c8869a9b16ea23e876,
title = "The therapeutic potential of psychedelics: the European regulatory perspective",
author = "Florence Butlen-Ducuing and McCulloch, {Drummond E.Wen} and Marion Haberkamp and Taina Mattila and Ewa Ba{\l}kowiec-Iskra and Georgios Aislaitner and Pavel Balabanov and Johan Lundberg and Stenb{\ae}k, {Dea Siggaard} and Andre Elferink and Knudsen, {Gitte M.} and Steffen Thirstrup",
note = "Funding Information: ST reports consulting fees paid directly to his former employee from Cybin, a pharmaceutical company developing psychedelics (no personal payment). DE-WM reports a PhD stipend paid for by an unrestricted grant from COMPASS Pathways, a commercial company involved in trials of psychedelic substances for mental health conditions, that had no involvement in the writing of this Comment. GMK reports grants or contracts from Lundbeck Foundation, Novo Nordisk Foundation, Danish Research Council, the EU and other funding bodies; payment or honoraria from Sage Biogen, Onsero, Pangea, H Lundbeck, and Angelini for consulting, lectures, presentations, or educational events; participation on data safety monitoring board or advisory board for the Human Brain Project, IMIM, Barcelona, and SGK Foundation; is a past President of the ECNP (not paid); and has Novo Nordisk stock options unrelated to the topic discussed (Novo Nordisk has no current therapies under investigation in this field). JL reports grants from the Swedish Research Council, lecture honorarium from Novartis, and financial support and in-kind work to provide investigational products (niacin and psilocybin) for researcher initiated phase 2b trial PSIPET (EudraCT-number: 2020-002790-94) from the non-profit Osmond Foundation. DSS reports grants from the Independent Research Fund Denmark, the Heath Foundation, and the Nordic Research Council; honoraria as speaker for the Lundbeck Foundation; and is a paid scientific adviser for Clerkenwell Health, a commercial company involved in trials of psychedelic substances for mental health conditions. The other authors declare no competing interests. This Comment comes from a collaboration between the EMA, the EMA's Central Nervous System Working Party, and the ECNP. The views expressed in this Comment are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the authors are employed or affiliated.",
year = "2023",
doi = "10.1016/S0140-6736(23)00264-7",
language = "English",
volume = "401",
pages = "714--716",
journal = "The Lancet",
issn = "0140-6736",
publisher = "TheLancet Publishing Group",
number = "10378",

}

RIS

TY - JOUR

T1 - The therapeutic potential of psychedelics

T2 - the European regulatory perspective

AU - Butlen-Ducuing, Florence

AU - McCulloch, Drummond E.Wen

AU - Haberkamp, Marion

AU - Mattila, Taina

AU - Bałkowiec-Iskra, Ewa

AU - Aislaitner, Georgios

AU - Balabanov, Pavel

AU - Lundberg, Johan

AU - Stenbæk, Dea Siggaard

AU - Elferink, Andre

AU - Knudsen, Gitte M.

AU - Thirstrup, Steffen

N1 - Funding Information: ST reports consulting fees paid directly to his former employee from Cybin, a pharmaceutical company developing psychedelics (no personal payment). DE-WM reports a PhD stipend paid for by an unrestricted grant from COMPASS Pathways, a commercial company involved in trials of psychedelic substances for mental health conditions, that had no involvement in the writing of this Comment. GMK reports grants or contracts from Lundbeck Foundation, Novo Nordisk Foundation, Danish Research Council, the EU and other funding bodies; payment or honoraria from Sage Biogen, Onsero, Pangea, H Lundbeck, and Angelini for consulting, lectures, presentations, or educational events; participation on data safety monitoring board or advisory board for the Human Brain Project, IMIM, Barcelona, and SGK Foundation; is a past President of the ECNP (not paid); and has Novo Nordisk stock options unrelated to the topic discussed (Novo Nordisk has no current therapies under investigation in this field). JL reports grants from the Swedish Research Council, lecture honorarium from Novartis, and financial support and in-kind work to provide investigational products (niacin and psilocybin) for researcher initiated phase 2b trial PSIPET (EudraCT-number: 2020-002790-94) from the non-profit Osmond Foundation. DSS reports grants from the Independent Research Fund Denmark, the Heath Foundation, and the Nordic Research Council; honoraria as speaker for the Lundbeck Foundation; and is a paid scientific adviser for Clerkenwell Health, a commercial company involved in trials of psychedelic substances for mental health conditions. The other authors declare no competing interests. This Comment comes from a collaboration between the EMA, the EMA's Central Nervous System Working Party, and the ECNP. The views expressed in this Comment are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the authors are employed or affiliated.

PY - 2023

Y1 - 2023

U2 - 10.1016/S0140-6736(23)00264-7

DO - 10.1016/S0140-6736(23)00264-7

M3 - Comment/debate

C2 - 36780909

AN - SCOPUS:85149396037

VL - 401

SP - 714

EP - 716

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10378

ER -

ID: 341272756