Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.

Guy M Goodwin; Scott T Aaronson; Oscar Alvarez; Peter C Arden; Annie Baker; James C Bennett; Catherine Bird; Renske E Blom; Christine Brennan; Donna Brusch; Lisa Burke; Kete Campbell-Coker; Robin Carhart-Harris; Joseph Cattell; Aster Daniel; Charles DeBattista; Boadie W Dunlop; Katherine Eisen; David Feifel; MacKenzie Forbes; Hannah M Haumann; David J Hellerstein; Astrid I Hoppe; Muhammad I Husain; Luke A Jelen; Jeanine Kamphuis; Julie Kawasaki; John R Kelly; Richard E Key; Ronit Kishon; Stephanie Knatz Peck; Gemma Knight; Martijn H B Koolen; Melanie Lean; Rasmus W. Licht; Jessica L Maples-Keller; Jan Mars; Lindsey Marwood; Martin C McElhiney; Tammy L Miller; Arvin Mirow; Sunil Mistry; Tanja Mletzko-Crowe; Liam N Modlin; René E. Nielsen; Elizabeth M Nielson; Sjoerd R Offerhaus; Veronica O'Keane; Tomáš Páleníček; David Printz; Marleen C Rademaker; Aumer van Reemst; Frederick Reinholdt; Dimitris Repantis; James Rucker; Samuel Rudow; Simon Ruffell; A John Rush; Robert A Schoevers; Mathieu Seynaeve; Samantha Shao; Jair C Soares; Metten Somers; Susan C Stansfield; Diane Sterling; Aaron Strockis; Joyce Tsai; Lucy Visser; Mourad Wahba; Samuel Williams; Allan H Young; Paula Ywema; Sidney Zisook; Ekaterina Malievskaia

doi:10.1056/NEJMoa2206443

Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.

Guy M Goodwin^*, Scott T Aaronson, Oscar Alvarez, Peter C Arden, Annie Baker, James C Bennett, Catherine Bird, Renske E Blom, Christine Brennan, Donna Brusch, Lisa Burke, Kete Campbell-Coker, Robin Carhart-Harris, Joseph Cattell, Aster Daniel, Charles DeBattista, Boadie W Dunlop, Katherine Eisen, David Feifel, MacKenzie ForbesHannah M Haumann, David J Hellerstein, Astrid I Hoppe, Muhammad I Husain, Luke A Jelen, Jeanine Kamphuis, Julie Kawasaki, John R Kelly, Richard E Key, Ronit Kishon, Stephanie Knatz Peck, Gemma Knight, Martijn H B Koolen, Melanie Lean, Rasmus W. Licht, Jessica L Maples-Keller, Jan Mars, Lindsey Marwood, Martin C McElhiney, Tammy L Miller, Arvin Mirow, Sunil Mistry, Tanja Mletzko-Crowe, Liam N Modlin, René E. Nielsen, Elizabeth M Nielson, Sjoerd R Offerhaus, Veronica O'Keane, Tomáš Páleníček, David Printz, Marleen C Rademaker, Aumer van Reemst, Frederick Reinholdt, Dimitris Repantis, James Rucker, Samuel Rudow, Simon Ruffell, A John Rush, Robert A Schoevers, Mathieu Seynaeve, Samantha Shao, Jair C Soares, Metten Somers, Susan C Stansfield, Diane Sterling, Aaron Strockis, Joyce Tsai, Lucy Visser, Mourad Wahba, Samuel Williams, Allan H Young, Paula Ywema, Sidney Zisook, Ekaterina Malievskaia

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

259 Citations (Scopus)

Abstract

BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P

Original language	English
Journal	The New England Journal of Medicine
Volume	387
Issue number	18
Pages (from-to)	1637-1648
Number of pages	12
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa2206443
Publication status	Published - 10 Nov 2022

Keywords

Adult
Antidepressive Agents
Depression
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Double-Blind Method
Humans
Psilocybin
Treatment Outcome
adverse effects
drug therapy
psychology
therapeutic use

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10.1056/NEJMoa2206443

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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., Burke, L., Campbell-Coker, K., Carhart-Harris, R., Cattell, J., Daniel, A., DeBattista, C., Dunlop, B. W., Eisen, K., Feifel, D., ... Malievskaia, E. (2022). Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. The New England Journal of Medicine, 387(18), 1637-1648. https://doi.org/10.1056/NEJMoa2206443

@article{ed91b9cf445b40dbba63843bb038eb26,

title = "Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.",

abstract = "BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-{\AA}sberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P",

keywords = "Adult, Antidepressive Agents, Depression, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Double-Blind Method, Humans, Psilocybin, Treatment Outcome, adverse effects, drug therapy, psychology, therapeutic use",

author = "Goodwin, {Guy M} and Aaronson, {Scott T} and Oscar Alvarez and Arden, {Peter C} and Annie Baker and Bennett, {James C} and Catherine Bird and Blom, {Renske E} and Christine Brennan and Donna Brusch and Lisa Burke and Kete Campbell-Coker and Robin Carhart-Harris and Joseph Cattell and Aster Daniel and Charles DeBattista and Dunlop, {Boadie W} and Katherine Eisen and David Feifel and MacKenzie Forbes and Haumann, {Hannah M} and Hellerstein, {David J} and Hoppe, {Astrid I} and Husain, {Muhammad I} and Jelen, {Luke A} and Jeanine Kamphuis and Julie Kawasaki and Kelly, {John R} and Key, {Richard E} and Ronit Kishon and {Knatz Peck}, Stephanie and Gemma Knight and Koolen, {Martijn H B} and Melanie Lean and Licht, {Rasmus W.} and Maples-Keller, {Jessica L} and Jan Mars and Lindsey Marwood and McElhiney, {Martin C} and Miller, {Tammy L} and Arvin Mirow and Sunil Mistry and Tanja Mletzko-Crowe and Modlin, {Liam N} and Nielsen, {Ren{\'e} E.} and Nielson, {Elizabeth M} and Offerhaus, {Sjoerd R} and Veronica O'Keane and Tom{\'a}{\v s} P{\'a}len{\'i}{\v c}ek and David Printz and Rademaker, {Marleen C} and {van Reemst}, Aumer and Frederick Reinholdt and Dimitris Repantis and James Rucker and Samuel Rudow and Simon Ruffell and Rush, {A John} and Schoevers, {Robert A} and Mathieu Seynaeve and Samantha Shao and Soares, {Jair C} and Metten Somers and Stansfield, {Susan C} and Diane Sterling and Aaron Strockis and Joyce Tsai and Lucy Visser and Mourad Wahba and Samuel Williams and Young, {Allan H} and Paula Ywema and Sidney Zisook and Ekaterina Malievskaia",

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month = nov,

day = "10",

doi = "10.1056/NEJMoa2206443",

language = "English",

volume = "387",

pages = "1637--1648",

journal = "The New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

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Goodwin, GM, Aaronson, ST, Alvarez, O, Arden, PC, Baker, A, Bennett, JC, Bird, C, Blom, RE, Brennan, C, Brusch, D, Burke, L, Campbell-Coker, K, Carhart-Harris, R, Cattell, J, Daniel, A, DeBattista, C, Dunlop, BW, Eisen, K, Feifel, D, Forbes, M, Haumann, HM, Hellerstein, DJ, Hoppe, AI, Husain, MI, Jelen, LA, Kamphuis, J, Kawasaki, J, Kelly, JR, Key, RE, Kishon, R, Knatz Peck, S, Knight, G, Koolen, MHB, Lean, M, Licht, RW, Maples-Keller, JL, Mars, J, Marwood, L, McElhiney, MC, Miller, TL, Mirow, A, Mistry, S, Mletzko-Crowe, T, Modlin, LN, Nielsen, RE, Nielson, EM, Offerhaus, SR, O'Keane, V, Páleníček, T, Printz, D, Rademaker, MC, van Reemst, A, Reinholdt, F, Repantis, D, Rucker, J, Rudow, S, Ruffell, S, Rush, AJ, Schoevers, RA, Seynaeve, M, Shao, S, Soares, JC, Somers, M, Stansfield, SC, Sterling, D, Strockis, A, Tsai, J, Visser, L, Wahba, M, Williams, S, Young, AH, Ywema, P, Zisook, S & Malievskaia, E 2022, 'Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.', The New England Journal of Medicine, vol. 387, no. 18, pp. 1637-1648. https://doi.org/10.1056/NEJMoa2206443

TY - JOUR

T1 - Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.

AU - Goodwin, Guy M

AU - Aaronson, Scott T

AU - Alvarez, Oscar

AU - Arden, Peter C

AU - Baker, Annie

AU - Bennett, James C

AU - Bird, Catherine

AU - Blom, Renske E

AU - Brennan, Christine

AU - Brusch, Donna

AU - Burke, Lisa

AU - Campbell-Coker, Kete

AU - Carhart-Harris, Robin

AU - Cattell, Joseph

AU - Daniel, Aster

AU - DeBattista, Charles

AU - Dunlop, Boadie W

AU - Eisen, Katherine

AU - Feifel, David

AU - Forbes, MacKenzie

AU - Haumann, Hannah M

AU - Hellerstein, David J

AU - Hoppe, Astrid I

AU - Husain, Muhammad I

AU - Jelen, Luke A

AU - Kamphuis, Jeanine

AU - Kawasaki, Julie

AU - Kelly, John R

AU - Key, Richard E

AU - Kishon, Ronit

AU - Knatz Peck, Stephanie

AU - Knight, Gemma

AU - Koolen, Martijn H B

AU - Lean, Melanie

AU - Licht, Rasmus W.

AU - Maples-Keller, Jessica L

AU - Mars, Jan

AU - Marwood, Lindsey

AU - McElhiney, Martin C

AU - Miller, Tammy L

AU - Mirow, Arvin

AU - Mistry, Sunil

AU - Mletzko-Crowe, Tanja

AU - Modlin, Liam N

AU - Nielsen, René E.

AU - Nielson, Elizabeth M

AU - Offerhaus, Sjoerd R

AU - O'Keane, Veronica

AU - Páleníček, Tomáš

AU - Printz, David

AU - Rademaker, Marleen C

AU - van Reemst, Aumer

AU - Reinholdt, Frederick

AU - Repantis, Dimitris

AU - Rucker, James

AU - Rudow, Samuel

AU - Ruffell, Simon

AU - Rush, A John

AU - Schoevers, Robert A

AU - Seynaeve, Mathieu

AU - Shao, Samantha

AU - Soares, Jair C

AU - Somers, Metten

AU - Stansfield, Susan C

AU - Sterling, Diane

AU - Strockis, Aaron

AU - Tsai, Joyce

AU - Visser, Lucy

AU - Wahba, Mourad

AU - Williams, Samuel

AU - Young, Allan H

AU - Ywema, Paula

AU - Zisook, Sidney

AU - Malievskaia, Ekaterina

PY - 2022/11/10

Y1 - 2022/11/10

N2 - BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P

AB - BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P

KW - Adult

KW - Antidepressive Agents

KW - Depression

KW - Depressive Disorder, Major

KW - Depressive Disorder, Treatment-Resistant

KW - Double-Blind Method

KW - Humans

KW - Psilocybin

KW - Treatment Outcome

KW - adverse effects

KW - drug therapy

KW - psychology

KW - therapeutic use

UR - http://www.scopus.com/inward/record.url?scp=85141170646&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2206443

DO - 10.1056/NEJMoa2206443

M3 - Journal article

SN - 0028-4793

VL - 387

SP - 1637

EP - 1648

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 18

ER -

Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.

Abstract

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Psilocybin for depression increases quality of life

Det bliver et rigtig stærkt våben mod depression

Det har i flere år været en tendens i Silicon Valley. Nu ankommer de ulovlige pakker dagligt til Københavns Lufthavn

Psykedelisk stof kan være en mulighed for depressionspatienter

Cite this

Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.

Abstract

Keywords

Access to Document

AUB Link

Other files and links

Fingerprint

Impacts

Psilocybin for depression increases quality of life

Press/Media

Det bliver et rigtig stærkt våben mod depression

Det har i flere år været en tendens i Silicon Valley. Nu ankommer de ulovlige pakker dagligt til Københavns Lufthavn

Psykedelisk stof kan være en mulighed for depressionspatienter

Cite this