Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life

Autor: Guy M. Goodwin, Scott T. Aaronson, Oscar Alvarez, Merve Atli, James C. Bennett, Megan Croal, Charles DeBattista, Boadie W. Dunlop, David Feifel, David J. Hellerstein, Muhammad Ishrat Husain, John R. Kelly, Molly R. Lennard-Jones, Rasmus W. Licht, Lindsey Marwood, Sunil Mistry, Tomáš Páleníček, Ozlem Redjep, Dimitris Repantis, Robert A. Schoevers, Batya Septimus, Hollie J. Simmons, Jair C. Soares, Metten Somers, Susan C. Stansfield, Jessica R. Stuart, Hannah H. Tadley, Nisha K. Thiara, Joyce Tsai, Mourad Wahba, Sam Williams, Rachel I. Winzer, Allan H. Young, Matthew B. Young, Sid Zisook, Ekaterina Malievskaia
Přispěvatelé: Faculteit Medische Wetenschappen/UMCG
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Journal of Affective Disorders, 327, 120-127. ELSEVIER SCIENCE BV
Goodwin, G M, Aaronson, S T, Alvarez, O, Atli, M, Bennett, J C, Croal, M, DeBattista, C, Dunlop, B W, Feifel, D, Hellerstein, D J, Husain, M I, Kelly, J R, Lennard-Jones, M R, Licht, R W, Marwood, L, Mistry, S, Páleníček, T, Redjep, O, Repantis, D, Schoevers, R A, Septimus, B, Simmons, H J, Soares, J C, Somers, M, Stansfield, S C, Stuart, J R, Tadley, H H, Thiara, N K, Tsai, J, Wahba, M, Williams, S, Winzer, R I, Young, A H, Young, M B, Zisook, S & Malievskaia, E 2023, ' Single-dose psilocybin for a treatment-resistant episode of major depression : Impact on patient-reported depression severity, anxiety, function, and quality of life ', Journal of Affective Disorders, vol. 327, pp. 120-127 . https://doi.org/10.1016/j.jad.2023.01.108
ISSN: 0165-0327
DOI: 10.1016/j.jad.2023.01.108
Popis: BACKGROUND: COMP360 is a proprietary, synthetic formulation of psilocybin being developed for treatment-resistant depression (TRD), a burdensome, life-threatening illness with high global impact. Here, we expand upon the previous report of primary outcomes from a phase 2 study of COMP360 in individuals with TRD-the largest randomised controlled clinical trial of psilocybin-to discuss findings of the exploratory efficacy endpoints.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.
Databáze: OpenAIRE
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