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The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression
GM. Goodwin, ST. Aaronson, O. Alvarez, R. Carhart-Harris, J. Chai-Rees, M. Croal, C. DeBattista, BW. Dunlop, D. Feifel, DJ. Hellerstein, MI. Husain, JR. Kelly, N. Kirlic, RW. Licht, L. Marwood, TD. Meyer, S. Mistry, A. Nowakowska, T. Páleníček,...
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články, randomizované kontrolované studie
- MeSH
- deprese nereagující na léčbu * farmakoterapie MeSH
- depresivní porucha unipolární farmakoterapie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- halucinogeny * aplikace a dávkování farmakologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- psilocybin * farmakologie aplikace a dávkování MeSH
- psychiatrické posuzovací škály MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression. METHODS: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support. The resulting psychedelic experience (Five-Dimensional Altered States of Consciousness questionnaire [5D-ASC] and Emotional Breakthrough Inventory [EBI]) were measured. These proximal variables and outcome 3 weeks post-administration (change in Montgomery-Åsberg Depression Rating Scale [MADRS]) were explored using correlation analysis. RESULTS: The mean intensity of psychedelic effects was dose-related, but distributions of scores for different doses overlapped considerably. Depression response correlated with select aspects of the psychedelic experience overall and for individual doses. At the 25 mg dose, 5D-ASC dimensions Oceanic Boundlessness (Pearson correlation coefficient r = -0.508) and Visual Restructuralization (r = -0.516), and EBI (r = -0·637) were the variables with the strongest correlation to the Week 3 change from Baseline in MADRS score. LIMITATIONS: The existence of correlation does not establish causation and exploratory findings require further replication, preferably in larger independent samples. CONCLUSIONS: The intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses.
Aalborg University Department of Clinical Medicine Aalborg Denmark
Aalborg University Hospital Department of Psychiatry Aalborg Denmark
Compass Pathfinder Ltd London UK
Compass Pathways Inc New York United States
Cumbria Northumberland Tyne and Wear NHS Foundation Trust UK
Department of Psychiatry University of California San Diego San Diego CA United States
Kadima Neuropsychiatry Institute San Diego CA United States
Newcastle University Newcastle upon Tyne UK
Parc Sanitari Sant Joan de Déu Barcelona Spain
Sant Joan de Déu Research Foundation Barcelona Spain
Stanford University Department of Psychiatry and Behavioral Sciences Stanford CA United States
Temerty Faculty of Medicine Department of Psychiatry University of Toronto Toronto Canada
The National Institute of Mental Health Klecany Czech Republic
University Medical Centre Groningen Department of Psychiatry Groningen the Netherlands
University of Maryland School of Medicine Department of Psychiatry Baltimore MD United States
Citace poskytuje Crossref.org
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- $a OBJECTIVE: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression. METHODS: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support. The resulting psychedelic experience (Five-Dimensional Altered States of Consciousness questionnaire [5D-ASC] and Emotional Breakthrough Inventory [EBI]) were measured. These proximal variables and outcome 3 weeks post-administration (change in Montgomery-Åsberg Depression Rating Scale [MADRS]) were explored using correlation analysis. RESULTS: The mean intensity of psychedelic effects was dose-related, but distributions of scores for different doses overlapped considerably. Depression response correlated with select aspects of the psychedelic experience overall and for individual doses. At the 25 mg dose, 5D-ASC dimensions Oceanic Boundlessness (Pearson correlation coefficient r = -0.508) and Visual Restructuralization (r = -0.516), and EBI (r = -0·637) were the variables with the strongest correlation to the Week 3 change from Baseline in MADRS score. LIMITATIONS: The existence of correlation does not establish causation and exploratory findings require further replication, preferably in larger independent samples. CONCLUSIONS: The intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses.
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