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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 and 64 more
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<0.001) and between the 10-mg group and 1-mg group was -2.5 (95% CI, -6.2 to 1.2; P = 0.18). In the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results. Adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness. Suicidal ideation or behavior or self-injury occurred in all dose groups. CONCLUSIONS: In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects. Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.).
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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. L., 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. New England Journal of Medicine, 387(18), 1637–1648. https://doi.org/10.1056/nejmoa2206443
Goodwin, Guy M., et al. "Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression." New England Journal of Medicine, vol. 387, no. 18, 2022, pp. 1637–1648, https://doi.org/10.1056/nejmoa2206443.
Goodwin, Guy M., Scott T. Aaronson, Oscar Alvarez, Peter C. Arden, Annie Baker, James C. Bennett, Catherine Bird, et al. "Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression." New England Journal of Medicine 387, no. 18 (2022): 1637–1648. https://doi.org/10.1056/nejmoa2206443.
Goodwin G. M., Aaronson S. T., Alvarez O. [и др.] Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression // New England Journal of Medicine. — 2022. — Vol. 387, № 18. — P. 1637–1648. — URL: https://doi.org/10.1056/nejmoa2206443
@article{goodwin2022singledose,
title = {{Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression}},
author = {Guy M. Goodwin and Scott T. Aaronson and Oscar Alvarez and Peter C. Arden and Annie Baker and James C. Bennett and Catherine Bird and Renske E. Blom and Christine Brennan and Donna Brusch and Lisa Burke and Kete Campbell‐Coker and Robin Lester Carhart-Harris and Joseph Cattell and Aster Daniel and Charles DeBattista and Boadie Waid Dunlop and Katherine Eisen and David Feifel and MacKenzie Forbes and Hannah M. Haumann and David J. Hellerstein and Astrid I. Hoppe and Muhammad Ishrat Husain and Luke A. Jelen and Jeanine Kamphuis and Julie Kawasaki and John Richard Kelly and Richard E. Key and Ronit Kishon and Stephanie Knatz Peck and Gemma Knight and Martijn H B Koolen and Melanie Lean and Rasmus Wentzer Licht and Jessica L. Maples‐Keller and Jan Mars and Lindsey Marwood and Martin C. McElhiney and Tammy L. Miller and Arvin L. Mirow and Sunil J. Mistry and Tanja Mletzko and Nadav Liam Modlin and René Ernst Nielsen and Elizabeth M. Nielson and S.R. Offerhaus and Veronica O’Keane and Tomáš Páleníček and David Printz and Marleen C. Rademaker and Aumer van Reemst and Frederick Reinholdt and Dimitris Repantis and James Rucker and Samuel Rudow and Simon Ruffell and Augustus John Rush and Robert A. Schoevers and Mathieu Seynaeve and Samantha Shao and Jair C. Soares and Metten Somers and S. C. Stansfield and Diane Sterling and Aaron Strockis and Joyce Tsai and Lucy Visser and Mourad Wahba and Samuel P. Williams and Allan Hunter Young and Paula Ywema and Sidney Zisook and Ekaterina Malievskaia},
journal = {New England Journal of Medicine},
year = {2022},
volume = {387},
number = {18},
pages = {1637--1648},
doi = {10.1056/nejmoa2206443},
url = {https://doi.org/10.1056/nejmoa2206443}
}TY - JOUR 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 Lester AU - Cattell, Joseph AU - Daniel, Aster AU - DeBattista, Charles AU - Dunlop, Boadie Waid AU - Eisen, Katherine AU - Feifel, David AU - Forbes, MacKenzie AU - Haumann, Hannah M. AU - Hellerstein, David J. AU - Hoppe, Astrid I. AU - Husain, Muhammad Ishrat AU - Jelen, Luke A. AU - Kamphuis, Jeanine AU - Kawasaki, Julie AU - Kelly, John Richard AU - Key, Richard E. AU - Kishon, Ronit AU - Peck, Stephanie Knatz AU - Knight, Gemma AU - Koolen, Martijn H B AU - Lean, Melanie AU - Licht, Rasmus Wentzer AU - Maples‐Keller, Jessica L. AU - Mars, Jan AU - Marwood, Lindsey AU - McElhiney, Martin C. AU - Miller, Tammy L. AU - Mirow, Arvin L. AU - Mistry, Sunil J. AU - Mletzko, Tanja AU - Modlin, Nadav Liam AU - Nielsen, René Ernst AU - Nielson, Elizabeth M. AU - Offerhaus, S.R. AU - O’Keane, Veronica AU - Páleníček, Tomáš AU - Printz, David AU - Rademaker, Marleen C. AU - Reemst, Aumer van AU - Reinholdt, Frederick AU - Repantis, Dimitris AU - Rucker, James AU - Rudow, Samuel AU - Ruffell, Simon AU - Rush, Augustus John AU - Schoevers, Robert A. AU - Seynaeve, Mathieu AU - Shao, Samantha AU - Soares, Jair C. AU - Somers, Metten AU - Stansfield, S. C. AU - Sterling, Diane AU - Strockis, Aaron AU - Tsai, Joyce AU - Visser, Lucy AU - Wahba, Mourad AU - Williams, Samuel P. AU - Young, Allan Hunter AU - Ywema, Paula AU - Zisook, Sidney AU - Malievskaia, Ekaterina TI - Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression JO - New England Journal of Medicine VL - 387 IS - 18 SP - 1637 EP - 1648 PY - 2022 DA - 2022/11/02 DO - 10.1056/nejmoa2206443 UR - https://doi.org/10.1056/nejmoa2206443 ER -
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