{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:18:13Z","timestamp":1791357493274,"version":"4.3.1"},"reference-count":30,"publisher":"Cambridge University Press (CUP)","issue":"5","license":[{"start":{"date-parts":[[2015,11,17]],"date-time":"2015-11-17T00:00:00Z","timestamp":1447718400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CNS Spectr."],"published-print":{"date-parts":[[2016,10]]},"abstract":"<jats:sec id=\"S1092852915000553_abs1\" sec-type=\"general\"><jats:title>Objective<\/jats:title><jats:p>Antidepressants are frequently associated with treatment-emergent sexual dysfunction (TESD). Vortioxetine, which was approved for patients with major depressive disorder (MDD), has a receptor profile that suggests limited impact on sexual functioning.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852915000553_abs2\" sec-type=\"methods\"><jats:title>Methods<\/jats:title><jats:p>Arizona Sexual Experiences Scale (ASEX) patient-level data were pooled from 7 short-term vortioxetine trials (6 in MDD, 1 in generalized anxiety disorder) and analyzed for incidence of TESD at any post-baseline visit in patients without sexual dysfunction at baseline (defined as ASEX total score \u226519; individual ASEX item score \u22655; or a score \u22654 on any 3 ASEX items). The primary objective was to confirm the non-inferiority of vortioxetine 5\u201320 mg\/day to placebo on the incidence of TESD. Comparisons were based on the common risk difference (95% confidence interval). Additional analyses compared vortioxetine to duloxetine and duloxetine to placebo. A sensitivity analysis, defined as TESD at 2 consecutive post-baseline visits, was conducted.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852915000553_abs3\" sec-type=\"results\"><jats:title>Results<\/jats:title><jats:p>TESD incidence, relative to placebo, generally increased with vortioxetine dose with vortioxetine 5 mg non-inferior to placebo. Vortioxetine 10, 15, and 20 mg did not meet the non-inferiority criterion, but no dose had a significantly higher risk of developing TESD versus placebo. Changes in ASEX individual item scores supported the similarity of vortioxetine doses to placebo. Significantly higher TESD risk occurred with duloxetine 60 mg\/day versus placebo and versus vortioxetine 5 or 10 mg. The sensitivity analysis was generally consistent with the primary analysis. Rates of spontaneously reported sexual adverse events were low.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852915000553_abs4\" sec-type=\"conclusions\"><jats:title>Conclusions<\/jats:title><jats:p>Vortioxetine was associated with rates of TESD that were not significantly different from placebo in short-term clinical trials.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s1092852915000553","type":"journal-article","created":{"date-parts":[[2015,11,17]],"date-time":"2015-11-17T10:25:21Z","timestamp":1447755921000},"page":"367-378","source":"Crossref","is-referenced-by-count":60,"title":["Treatment-emergent sexual dysfunction in randomized trials of vortioxetine for major depressive disorder or generalized anxiety disorder: a pooled analysis"],"prefix":"10.1017","volume":"21","author":[{"given":"Paula L.","family":"Jacobsen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atul R.","family":"Mahableshwarkar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William A.","family":"Palo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinzhong","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Dragheim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita H.","family":"Clayton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2015,11,17]]},"reference":[{"key":"S1092852915000553_ref2","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e31819c76e9"},{"key":"S1092852915000553_ref9","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v65n0712"},{"key":"S1092852915000553_ref25","volume-title":"Diagnostic and Statistical Manual of Mental Disorders","year":"2000"},{"key":"S1092852915000553_ref3","first-page":"10","article-title":"Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. 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