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A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults
OBJECTIVE: To evaluate single zuranolone (SAGE‐217) 30 or 45 mg doses in a 5‐h phase advance insomnia model. METHODS: In this double‐blind, three‐way crossover study, healthy adults received placebo (n = 41), zuranolone 30 mg (n = 44), and zuranolone 45 mg (n = 42) across three treatment periods. Sl...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286466/ https://www.ncbi.nlm.nih.gov/pubmed/34352138 http://dx.doi.org/10.1002/hup.2806 |
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author | Bullock, Amy Gunduz‐Bruce, Handan Zammit, Gary K. Qin, Min Li, Haihong Sankoh, Abdul J. Silber, Christopher Kanes, Stephen J. Jonas, Jeffrey Doherty, James |
author_facet | Bullock, Amy Gunduz‐Bruce, Handan Zammit, Gary K. Qin, Min Li, Haihong Sankoh, Abdul J. Silber, Christopher Kanes, Stephen J. Jonas, Jeffrey Doherty, James |
author_sort | Bullock, Amy |
collection | PubMed |
description | OBJECTIVE: To evaluate single zuranolone (SAGE‐217) 30 or 45 mg doses in a 5‐h phase advance insomnia model. METHODS: In this double‐blind, three‐way crossover study, healthy adults received placebo (n = 41), zuranolone 30 mg (n = 44), and zuranolone 45 mg (n = 42) across three treatment periods. Sleep was assessed by polysomnography and a postsleep questionnaire. Next‐day residual effects and safety/tolerability were evaluated. RESULTS: Compared with placebo, zuranolone resulted in significant improvements in median sleep efficiency (30 mg, 84.6%; 45 mg, 87.6%; placebo, 72.9%; p < 0.001 for both doses), wake after sleep onset (WASO; 30 mg, 55.0 min; 45 mg, 42.5 min; placebo, 113.0 min; p < 0.001 for both doses), duration of awakenings (30 mg, 4.2 min, p < 0.001; 45 mg, 3.7 min, p = 0.001; placebo, 7.4 min), and total sleep time (TST; 30 mg, 406.3 min; 45 mg, 420.3 min; placebo, 350.0 min; p < 0.001 for both doses). Subjective endpoints (WASO, TST, sleep latency, sleep quality) also improved relative to placebo. Zuranolone was generally well tolerated, and the most common adverse events (≥2 participants, any period) were headache and fatigue. CONCLUSION: Zuranolone improved sleep measures versus placebo in a phase advance model of insomnia in healthy adults, supporting future studies in patients with insomnia disorder. |
format | Online Article Text |
id | pubmed-9286466 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92864662022-07-19 A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults Bullock, Amy Gunduz‐Bruce, Handan Zammit, Gary K. Qin, Min Li, Haihong Sankoh, Abdul J. Silber, Christopher Kanes, Stephen J. Jonas, Jeffrey Doherty, James Hum Psychopharmacol Research Articles OBJECTIVE: To evaluate single zuranolone (SAGE‐217) 30 or 45 mg doses in a 5‐h phase advance insomnia model. METHODS: In this double‐blind, three‐way crossover study, healthy adults received placebo (n = 41), zuranolone 30 mg (n = 44), and zuranolone 45 mg (n = 42) across three treatment periods. Sleep was assessed by polysomnography and a postsleep questionnaire. Next‐day residual effects and safety/tolerability were evaluated. RESULTS: Compared with placebo, zuranolone resulted in significant improvements in median sleep efficiency (30 mg, 84.6%; 45 mg, 87.6%; placebo, 72.9%; p < 0.001 for both doses), wake after sleep onset (WASO; 30 mg, 55.0 min; 45 mg, 42.5 min; placebo, 113.0 min; p < 0.001 for both doses), duration of awakenings (30 mg, 4.2 min, p < 0.001; 45 mg, 3.7 min, p = 0.001; placebo, 7.4 min), and total sleep time (TST; 30 mg, 406.3 min; 45 mg, 420.3 min; placebo, 350.0 min; p < 0.001 for both doses). Subjective endpoints (WASO, TST, sleep latency, sleep quality) also improved relative to placebo. Zuranolone was generally well tolerated, and the most common adverse events (≥2 participants, any period) were headache and fatigue. CONCLUSION: Zuranolone improved sleep measures versus placebo in a phase advance model of insomnia in healthy adults, supporting future studies in patients with insomnia disorder. John Wiley and Sons Inc. 2021-08-05 2022-01 /pmc/articles/PMC9286466/ /pubmed/34352138 http://dx.doi.org/10.1002/hup.2806 Text en © 2021 Sage Therapeutics Inc. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Research Articles Bullock, Amy Gunduz‐Bruce, Handan Zammit, Gary K. Qin, Min Li, Haihong Sankoh, Abdul J. Silber, Christopher Kanes, Stephen J. Jonas, Jeffrey Doherty, James A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults |
title | A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults |
title_full | A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults |
title_fullStr | A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults |
title_full_unstemmed | A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults |
title_short | A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults |
title_sort | phase 1 double‐blind, placebo‐controlled study of zuranolone (sage‐217) in a phase advance model of insomnia in healthy adults |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286466/ https://www.ncbi.nlm.nih.gov/pubmed/34352138 http://dx.doi.org/10.1002/hup.2806 |
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