{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T16:59:22Z","timestamp":1789664362421,"version":"4.0.1"},"reference-count":38,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2024,10,11]],"date-time":"2024-10-11T00:00:00Z","timestamp":1728604800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,10,11]],"date-time":"2024-10-11T00:00:00Z","timestamp":1728604800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Zuranolone is an oral, once-daily, 14-day treatment course approved for adults with postpartum depression in the United States.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>To assess cognitive effects, pharmacokinetics, and safety of zuranolone, alone or with alprazolam\/ethanol.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This was a phase 1, two-part, two-period, randomized, double-blind, placebo-controlled crossover trial. Participants received zuranolone 50\u2009mg or placebo once daily for 9\u2009days, and additionally received alprazolam (1\u2009mg, Part A), ethanol (males: 0.7 g\/kg; females: 0.6 g\/kg, Part B), or corresponding placebo on days 1, 5, and 9. Within each part, participants received all treatment combinations. Cognition was assessed using a computerized test battery; pharmacokinetics and safety were also evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      All participants (Part A,\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      \u2009=\u200924; Part B,\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      \u2009=\u200925) received \u2a7e1 dose of zuranolone\/placebo. Compared to placebo, zuranolone produced small-to-moderate cognitive decline (Cohen\u2019s |\n                      <jats:italic toggle=\"yes\">d<\/jats:italic>\n                      |\u2009=\u20090.126\u20130.76); effects were larger with alprazolam (Cohen\u2019s |\n                      <jats:italic toggle=\"yes\">d<\/jats:italic>\n                      |\u2009=\u20090.523\u20130.93) and ethanol (Cohen\u2019s |\n                      <jats:italic toggle=\"yes\">d<\/jats:italic>\n                      |\u2009=\u20090.345\u20130.88). Zuranolone coadministration with alprazolam (Cohen\u2019s |\n                      <jats:italic toggle=\"yes\">d<\/jats:italic>\n                      |\u2009=\u20090.6\u20131.227) or ethanol (Cohen\u2019s |\n                      <jats:italic toggle=\"yes\">d<\/jats:italic>\n                      |\u2009=\u20090.054\u20130.5) generally worsened cognitive decline when compared with zuranolone alone. Maximal pharmacodynamic effects occurred at approximately 5\u2009h and were resolved by 12\u2009h postbaseline. No pharmacokinetic interactions were observed. Incidence of adverse events was similar between groups; most events were mild or moderate in severity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>A general small-to-moderate magnitude decline in cognition occurred with zuranolone alone. Coadministration with alprazolam\/ethanol increased the magnitude, but not the duration, of effects compared with single-agent administration. Zuranolone prescribers and patients should be aware of the potential for increased central nervous system-depressant effects if coadministered with GABAergic active compounds such as alprazolam and ethanol.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/02698811241282777","type":"journal-article","created":{"date-parts":[[2024,10,12]],"date-time":"2024-10-12T01:18:21Z","timestamp":1728695901000},"page":"1122-1136","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["Cognitive effects, pharmacokinetics, and safety of zuranolone administered alone or with alprazolam or ethanol in healthy adults in a phase 1 trial"],"prefix":"10.1177","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7663-1535","authenticated-orcid":false,"given":"Joi","family":"Dunbar","sequence":"first","affiliation":[{"name":"Sage Therapeutics, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David P","family":"Walling","sequence":"additional","affiliation":[{"name":"CenExel CNS, Los Alamitos, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard A","family":"Hassman","sequence":"additional","affiliation":[{"name":"CenExel Hassman Research Institute, Marlton, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakesh","family":"Jain","sequence":"additional","affiliation":[{"name":"Texas Tech University School of Medicine, Austin, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andy","family":"Czysz","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Indrani","family":"Nandy","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7834-6452","authenticated-orcid":false,"given":"Victor","family":"Ona","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret K","family":"Moseley","sequence":"additional","affiliation":[{"name":"Biogen, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth","family":"Levin","sequence":"additional","affiliation":[{"name":"Biogen, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Maruff","sequence":"additional","affiliation":[{"name":"Cogstate, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,10,11]]},"reference":[{"key":"e_1_3_3_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000005200"},{"key":"e_1_3_3_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2020.108333"},{"key":"e_1_3_3_4_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.books.9780890425596"},{"key":"e_1_3_3_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2017.10.032"},{"key":"e_1_3_3_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/00004714-199008000-00003"},{"key":"e_1_3_3_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.117.244673"},{"key":"e_1_3_3_8_1","volume-title":"Statistical Power Analysis for the Behavioral Sciences","author":"Cohen J","year":"1988","unstructured":"Cohen J (1988) Statistical Power Analysis for the Behavioral Sciences. 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