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