학술논문

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication.
Document Type
Academic Journal
Author
Goodwin GM; COMPASS Pathfinder Ltd, London, United Kingdom. guy.goodwin@compasspathways.com.; Croal M; COMPASS Pathfinder Ltd, London, United Kingdom.; Feifel D; Kadima Neuropsychiatry Institute, San Diego, CA, USA.; Kelly JR; Department of Psychiatry, Trinity Centre for Health Sciences, Tallaght University Hospital, Dublin, Ireland.; Marwood L; COMPASS Pathfinder Ltd, London, United Kingdom.; Mistry S; COMPASS Pathfinder Ltd, London, United Kingdom.; O'Keane V; Department of Psychiatry, Trinity Centre for Health Sciences, Tallaght University Hospital, Dublin, Ireland.; Peck SK; Department of Psychiatry, University of California San Diego, San Diego, CA, USA.; Simmons H; COMPASS Pathfinder Ltd, London, United Kingdom.; Sisa C; COMPASS Pathfinder Ltd, London, United Kingdom.; Stansfield SC; COMPASS Pathfinder Ltd, London, United Kingdom.; Tsai J; COMPASS Pathfinder Ltd, London, United Kingdom.; Williams S; COMPASS Pathfinder Ltd, London, United Kingdom.; Malievskaia E; COMPASS Pathfinder Ltd, London, United Kingdom.
Source
Publisher: Nature Publishing Group Country of Publication: England NLM ID: 8904907 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1740-634X (Electronic) Linking ISSN: 0893133X NLM ISO Abbreviation: Neuropsychopharmacology Subsets: MEDLINE
Subject
Language
English
Abstract
Psilocybin is being investigated as a treatment in adults with treatment-resistant depression (TRD). Withdrawal from serotonergic antidepressant drugs is a common prerequisite for taking part in trials of psilocybin due to the possibility of ongoing antidepressant drugs altering the psychedelic effect. This phase II, exploratory, international, fixed-dose, open-label study explored the safety, tolerability, and efficacy of a synthetic form of psilocybin (investigational drug COMP360) adjunct to a selective serotonin reuptake inhibitor in participants with TRD. Participants received a single 25 mg dose of psilocybin alongside psychological support and were followed-up for 3 weeks. The primary efficacy end point was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from Baseline at Week 3. Secondary end points were safety, including treatment-emergent adverse events (TEAEs), the proportion of responders and remitters at Week 3, and the change from Baseline to Week 3 in Clinical Global Impression-Severity (CGI-S) score. Nineteen participants were dosed and the mean Baseline MADRS total score was 31.7 (SD = 5.77). Twelve (63.2%) participants had a TEAE, most of which were mild and resolved on the day of onset. There were no serious TEAEs or indication of increased suicidal ideation or behavior. At Week 3, mean change from Baseline in MADRS total score was -14.9 (95% CI, -20.7 to -9.2), and -1.3 (SD = 1.29) in the CGI-S. Both response and remission were evident in 8 (42.1%) participants. Larger, comparator-controlled trials are necessary to understand if this paradigm can optimize treatment-outcome where antidepressant drug withdrawal would be problematic.
(© 2023. The Author(s).)