{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T05:58:43Z","timestamp":1770962323155,"version":"3.50.1"},"reference-count":46,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2005,5,24]],"date-time":"2005-05-24T00:00:00Z","timestamp":1116892800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Human Psychopharmacology"],"published-print":{"date-parts":[[2005,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To examine the safety and tolerability of the antidepressant duloxetine across multiple studies for major depressive disorder (MDD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Safety data were integrated from the acute phases of eight double\u2010blind, placebo\u2010controlled trials in which patients were randomized to duloxetine (40\u2013120\u2009mg\/d; <jats:italic>n<\/jats:italic>\u2009=\u20091139) or placebo (<jats:italic>n<\/jats:italic>\u2009=\u2009777) for up to 9 weeks. This data set included all acute\u2010phase clinical trials that formed the basis of the New Drug Application (United States) or European Union submission package for duloxetine in the treatment of MDD. Two studies included continuation phases in which acute treatment responders received duloxetine or placebo for an additional 26 weeks. Safety assessments included serious adverse event reports, rates of discontinuation, spontaneously reported treatment\u2010emergent adverse events, changes in vital signs and laboratory values, and electrocardiograms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The rates of serious adverse events for duloxetine\u2010 and placebo\u2010treated patients were 0.3% and 0.6%, respectively (<jats:italic>p<\/jats:italic>\u2009=\u20090.282). Adverse events led to discontinuation in 9.7% of duloxetine\u2010treated patients, compared with 4.2% of patients receiving placebo (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Treatment\u2010emergent adverse events with an incidence for duloxetine \u2265\u20095.0% and significantly greater than placebo were nausea, dry mouth, constipation, insomnia, dizziness, fatigue, somnolence, increased sweating and decreased appetite. Mean changes in blood pressure and heart rate were small, and the incidence of increases above normal ranges was low. Duloxetine\u2010treated patients had a mean decrease in weight of 0.5\u2009kg compared with an increase of 0.2\u2009kg for patients receiving placebo (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). No significant differences were found between duloxetine and placebo in the incidence of potentially clinically significant laboratory values at anytime while on treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These results are consistent with those obtained previously from smaller pooled data sets, and suggest that duloxetine is safe and well tolerated in patients with MDD. 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