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Original ArticleFree Preview


SINGLE-DOSE PSILOCYBIN FOR A TREATMENT-RESISTANT EPISODE OF MAJOR DEPRESSION

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

November 3, 2022
N Engl J Med 2022; 387:1637-1648
DOI: 10.1056/NEJMoa2206443


 * Related Articles


ABSTRACT


BACKGROUND

Psilocybin is being studied for use in treatment-resistant depression.


METHODS

Download a PDF of the Research Summary.

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. opens in new tab; ClinicalTrials.gov number,
NCT03775200. opens in new tab.)

QUICK TAKE VIDEO SUMMARY
Psilocybin for Treatment-Resistant Depression
 02:25


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FUNDING AND DISCLOSURES

Supported by COMPASS Pathfinder.

Disclosure forms provided by the authors are available with the full text of
this article at NEJM.org.

The views expressed are those of the authors and not necessarily those of the
NHS, the National Institute for Health or Care Research, or the Department of
Health and Social Care in the United Kingdom.

This article was updated on November 3, 2022, at NEJM.org.

A data sharing statement provided by the authors is available with the full text
of this article at NEJM.org.

We thank the participants, without whom this research would not have been
possible; the following staff members at COMPASS Pathfinder and Worldwide
Clinical Trials for their contributions: Molly Lennard-Jones, Rachel Winzer,
Batya Septimus, Merve Atli, Ozlem Redjep, Hannah Tadley, Nisha Thiara, Hollie
Simmons, Julia Forte, Niccolo Bassani, and Alexandra Novikova; Edward Schweizer
for helping with the first draft of the manuscript; Megan Croal for helping
revise subsequent drafts; the staff at all the sites for help with recruitment
of participants, including the Champalimaud Foundation (Portugal), Hospital del
Mar (Spain), Leiden UMC (the Netherlands), and St. Pancras Clinical Research
(United Kingdom); and Bill Richards, Mike Emmanuel, and Mary Johnson for their
advice in designing the trial originally.


AUTHOR AFFILIATIONS

From COMPASS Pathfinder (G.M.G., J.C.B., L.M., S.M., S.C.S., J.T., S.W., E.M.),
the Department of Psychological Medicine, Institute of Psychiatry, Psychology,
and Neuroscience, King’s College London (C. Bird, L.A.J., G.K., L.N.M., F.R.,
J.R., S. Ruffell, M. Seynaeve, A.H.Y.), the National Institute for Health and
Care Research Clinical Research Facility, King’s College Hospital NHS Foundation
Trust (K.C.-C., J.C., A.D.), and South London and Maudsley NHS Foundation Trust,
Bethlem Royal Hospital (L.A.J., L.N.M., J.R., A.H.Y.), London, and the Cumbria,
Northumberland, Tyne and Wear Foundation Trust and Newcastle University,
Newcastle (M.W.) — all in the United Kingdom; the Institute for Advanced
Diagnostics and Therapeutics, Sheppard Pratt, Baltimore (S.T.A., M.F., T.L.M.,
S. Rudow); Sant Joan de Déu Hospital and the Sant Joan de Déu Research
Foundation, Barcelona (O.A.); SUNY Downstate College of Medicine (P.C.A.), the
New York State Psychiatric Institute (D.J.H., R.E.K., R.K., M.C.M., E.M.N.), and
the Department of Psychiatry, Columbia University (D.J.H., R.K., M.C.M., E.M.N.)
— all in New York; the Department of Psychiatry, Trinity Centre for Health
Sciences, Tallaght University Hospital, Dublin (A.B., C. Brennan, L.B., J.R.K.,
V.O.); the Department of Psychiatry, University Medical Center (UMC) Utrecht
Brain Center, University Medical Center Utrecht, Utrecht (R.E.B., H.M.H.,
A.I.H., M.H.B.K., S.R.O., M.C.R., A.R., M. Somers, L.V., P.Y.), the Research
Department, GGz Centraal Innova, Amersfoort (R.E.B.), and the Department of
Psychiatry, UMC Groningen, Groningen (J. Kamphuis, J.M., R.A.S.) — all in the
Netherlands; the Department of Psychiatry, University of California San Diego
(D.B., J. Kawasaki, S.K.P., D.P., S.S., A.S., S.Z.), and Kadima Neuropsychiatry
Institute (D.F., S.K.P., A.M., D.S.), La Jolla, the Weill Institute for
Neurosciences, University of California San Francisco, San Francisco (R.C.-H.),
and the Department of Psychiatry and Behavioral Sciences, Stanford University,
Stanford (C.D., K.E., M.L.) — all in California; the Department of Psychiatry
and Behavioral Sciences, Emory University School of Medicine, Atlanta (B.W.D.,
J.L.M.-K., T.M.-C.); the Campbell Family Mental Health Research Institute,
Centre for Addiction and Mental Health, and the Department of Psychiatry,
University of Toronto, Toronto (M.I.H.); the Department of Psychiatry, Aalborg
University Hospital, and the Department of Clinical Medicine, Aalborg
University, Aalborg, Denmark (R.W.L., R.E.N.); the National Institute of Mental
Health, Klecany, Czech Republic (T.P.); Charité–Universitätsmedizin Berlin,
Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin
(D.R.); Duke University School of Medicine, Durham, NC (A.J.R.); and the
University of Texas (UT) Harris County Psychiatric Center and the UT Center of
Excellence on Mood Disorders, Department of Psychiatry and Behavioral Sciences,
UT Houston Medical School, Houston (J.C.S.).

Dr. Goodwin can be contacted at guy.goodwin@compasspathways.com.

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November 3, 2022
N Engl J Med 2022; 387:1637-1648
DOI: 10.1056/NEJMoa2206443


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