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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThis article presents a poster with results of a Phase 3 trial to evaluate the efficacy and tolerability of levomilnacipran extended-release (ER) dose in adult patients with major depressive disorder [APA 2014 (poster NR6-087); \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00969709\u0026amp;atom=%2Fspmdc%2F14%2F8%2F20.1.atom\u0022\u003ENCT00969709\u003C\/a\u003E]. The results of the study indicated that higher doses of levomilnacipran ER may benefit some patients, including those with moderate to severe depression.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychopharmacology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMood Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychopharmacology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMood Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EGregory M. Asnis, MD, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA, presented a poster with results of a Phase 3 trial to evaluate the efficacy and tolerability of levomilnacipran extended-release (ER) dose in adult patients with major depressive disorder (MDD)[APA2014 (poster NR6\u2013087); \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00969709\u0026amp;atom=%2Fspmdc%2F14%2F8%2F20.1.atom\u0022\u003ENCT00969709\u003C\/a\u003E]. The results of the study indicated that higher doses of levomilnacipran ER may benefit some patients, including those with moderate to severe depression.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ELevomilnacipran ER, a potent, selective serotonin and norepinephrine reuptake inhibitor (SNRI), is approved for use in the treatment of MDD in adults, with dose-proportional pharmacokinetic effects demonstrated in some studies [Chen L et al. APA 2013 (poster NR9\u201337)].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ETo be included in the 8-week, double-blind, multicenter, parallel-group, placebo-controlled study, patients were required to be 18 to 65 years and meet \u003Cem\u003EDSM-IV-TR\u003C\/em\u003E criteria for MDD, with a current major depressive episode \u22658 weeks, and a score of \u226530 on the Montgomery-Asberg Depression Rating Scale (MADRS). Patients were randomized to placebo (n=179) or once-daily levomilnacipran ER 40 mg (n=181), 80 mg (n=181), or 120 mg (n=183); doses were initiated at 20 mg and titrated to the target dose over 7 days.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EExclusion criteria included patients with various psychiatric conditions, as well as nonpsychiatric conditions that may interfere with the study. Those with a history of nonresponse to \u22652 antidepressants were also excluded.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn the intention-to-treat (ITT) patient population, the primary outcome was the change in MADRS total score from baseline to the end of Week 8. Secondary outcome was Sheehan Disability Scale (SDS) total score.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ELeast squares mean difference (LSMD) was used to assess the relationship between levomilnacipran dose and efficacy. Compared with placebo, the LSMD for depressive symptoms (MADRS total score change) was significantly different (p=0.0186; p=0.0038; p=0.0005) for all levomilnacipran ER dose groups (40 mg, \u22123.23; 80 mg, \u22123.99; 120 mg, \u22124.86). The data also suggested a linear relationship between dose and efficacy.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn patients with more severe MDD (baseline MADRS \u226535), LSMD values demonstrated that improvements in depressive symptoms were significantly greater in the 80 mg (\u22125.14; p=0.0098) and 120 mg (\u22126.21; p=0.0016) groups, but not in the 40 mg group (\u22123.81; p=0.0558).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EOn the SDS, the LSMD was also significantly different for the levomilnacipran ER 80 mg (\u22122.51; p=0.0151) and 120 mg (\u22122.57; p=0.0141) groups but not for the 40 mg group (\u22121.41; p=0.1687).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ELevomilnacipran ER was generally well-tolerated across the dosage groups. Serious adverse events (AEs) occurred in \u22642% of patients in all treatment groups, with no deaths reported. The incidence of treatment-emergent adverse events (TEAEs) was 63.6% in the placebo group, and was similar across all three levomilnacipran ER dosage groups (40 mg, 75.8%; 80 mg, 82.7%; 120 mg, 76.7%). However, a dose-related effect was observed for urinary hesitation and erectile dysfunction, which occurred in 6.1% and 9.5% of patients in the 120-mg group, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EIn summary, higher doses of levomilnacipran ER are associated with greater improvements in MADRS and SDS, with no overall increase in the incidence of TEAEs with higher doses. Higher doses of levomilnacipran ER may therefore benefit some patients with MDD, including those with more severe symptoms, concluded Dr. Asnis.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/8\/20.1.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp8hd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}