Psilocybin-assisted psychotherapy for treatment resistant depression: A randomized clinical trial evaluating repeated doses of psilocybin.
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Rosenblat Joshua D, Meshkat Shakila, Doyle Zoe, Kaczmarek Erica, Brudner Ryan M, Kratiuk Kevin, Mansur Rodrigo B, Schulz-Quach Christian, Sethi Rickinder, Abate Amanda, Ali Shaun, Bawks Jordan, Blainey Marc G, Brietzke Elisa, Cronin Victoria, Danilewitz Jessica, Dhawan Shalini, Di Fonzo Anthony, Di Fonzo Melissa, Drzadzewski Pawel, Dunlop William, Fiszter Hajnalka, Gomes Fabiano A, Grewal Smrita, Leon-Carlyle Marisa, McCallum Marilyn, Mofidi Niki, Offman Hilary, Riva-Cambrin Jeremy, Schmidt Joel, Smolkin Mark, Quinn Joan M, Zumrova Andrea, Marlborough Michelle, McIntyre Roger S
Аннотация
METHODS: Adults with treatment-resistant depression as part of major depressive or bipolar II disorder without psychosis or a substance use disorder were eligible to participate. Subjects were randomized to immediate treatment or waitlist control, with all eventually receiving PAP. Participants had one, two, or three psilocybin sessions with a fixed dose of 25 mg. Each dose was accompanied by preparation and integration psychotherapy sessions. Acceptability, safety, tolerability, and efficacy were evaluated (this study was registered at ClinicalTrials.gov: NCT05029466).
FINDINGS: Participants were randomized to immediate treatment (n = 16) or delayed treatment (n = 14). 29/30 were retained to the week-2 primary endpoint. Adverse events were transient, with no serious adverse events. Greater reductions in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) were observed in the immediate treatment arm compared to the waitlist period arm with a large hedge's g effect size of 1.07 (p < 0.01). Repeated doses were associated with further reductions in MADRS scores compared to baseline.
CONCLUSIONS: PAP was feasible in complex patients with preliminary antidepressant efficacy and adequate safety and tolerability. Repeated doses were associated with greater reductions in depression severity.
FUNDING: This work was funded by Brain and Cognition Discovery Foundation (BCDF), Usona, and Braxia Scientific.