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Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication
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 effe...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10425429/ https://www.ncbi.nlm.nih.gov/pubmed/37443386 http://dx.doi.org/10.1038/s41386-023-01648-7 |
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author | Goodwin, Guy M. Croal, Megan Feifel, David Kelly, John R. Marwood, Lindsey Mistry, Sunil O’Keane, Veronica Peck, Stephanie Knatz Simmons, Hollie Sisa, Claudia Stansfield, Susan C. Tsai, Joyce Williams, Sam Malievskaia, Ekaterina |
author_facet | Goodwin, Guy M. Croal, Megan Feifel, David Kelly, John R. Marwood, Lindsey Mistry, Sunil O’Keane, Veronica Peck, Stephanie Knatz Simmons, Hollie Sisa, Claudia Stansfield, Susan C. Tsai, Joyce Williams, Sam Malievskaia, Ekaterina |
author_sort | Goodwin, Guy M. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10425429 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-104254292023-08-16 Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication Goodwin, Guy M. Croal, Megan Feifel, David Kelly, John R. Marwood, Lindsey Mistry, Sunil O’Keane, Veronica Peck, Stephanie Knatz Simmons, Hollie Sisa, Claudia Stansfield, Susan C. Tsai, Joyce Williams, Sam Malievskaia, Ekaterina Neuropsychopharmacology Article 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. Springer International Publishing 2023-07-13 2023-09 /pmc/articles/PMC10425429/ /pubmed/37443386 http://dx.doi.org/10.1038/s41386-023-01648-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Goodwin, Guy M. Croal, Megan Feifel, David Kelly, John R. Marwood, Lindsey Mistry, Sunil O’Keane, Veronica Peck, Stephanie Knatz Simmons, Hollie Sisa, Claudia Stansfield, Susan C. Tsai, Joyce Williams, Sam Malievskaia, Ekaterina Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication |
title | Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication |
title_full | Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication |
title_fullStr | Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication |
title_full_unstemmed | Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication |
title_short | Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication |
title_sort | psilocybin for treatment resistant depression in patients taking a concomitant ssri medication |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10425429/ https://www.ncbi.nlm.nih.gov/pubmed/37443386 http://dx.doi.org/10.1038/s41386-023-01648-7 |
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