Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life.
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Goodwin Guy M, Aaronson Scott T, Alvarez Oscar, Atli Merve, Bennett James C, Croal Megan, DeBattista Charles, Dunlop Boadie W, Feifel David, Hellerstein David J, Husain Muhammad Ishrat, Kelly John R, Lennard-Jones Molly R, Licht Rasmus W, Marwood Lindsey, Mistry Sunil, Páleníček Tomáš, Redjep Ozlem, Repantis Dimitris, Schoevers Robert A, Septimus Batya, Simmons Hollie J, Soares Jair C, Somers Metten, Stansfield Susan C, Stuart Jessica R, Tadley Hannah H, Thiara Nisha K, Tsai Joyce, Wahba Mourad, Williams Sam, Winzer Rachel I, Young Allan H, Young Matthew B, Zisook Sid, Malievskaia Ekaterina
Аннотация
METHODS: In this phase 2, double-blind trial, 233 participants with TRD were randomised to receive a single dose of psilocybin 25 mg, 10 mg, or 1 mg (control), administered alongside psychological support from trained therapists. Efficacy measures assessed patient-reported depression severity, anxiety, positive and negative affect, functioning and associated disability, quality of life, and cognitive function.
RESULTS: At Week 3, psilocybin 25 mg, compared with 1 mg, was associated with greater improvements from Baseline total scores in all measures. The 10 mg dose produced smaller effects across these measures.
LIMITATIONS: Interpretation of this trial is limited by the absence of an active comparator and the possibility of functional unblinding in participants who received a low dose of psilocybin.
CONCLUSIONS: Three weeks after dosing, psilocybin 25 mg and, to a lesser degree, 10 mg improved measures of patient-reported depression severity, anxiety, affect, and functioning. These results extend the primary findings from the largest randomised clinical trial of psilocybin for TRD to examine other outcomes that are of importance to patients.