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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\u003EA multicenter, randomized, double-blind, placebo-controlled trial involving more than 1100 patients with major depressive disorder has affirmed the efficacy and safety of vilazodone 40 mg\/day and indicated the acceptability of a dose of 20 mg\/day [APA 2014 (poster NR6-103)].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMood Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychopharmacology\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMood Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychopharmacology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA multicenter, randomized, double-blind, placebo-controlled trial involving more than 1100 patients with major depressive disorder (MDD) has affirmed the efficacy and safety of vilazodone (VLZ) 40 mg\/day and indicated the acceptability of a dose of 20 mg\/day. The poster presenter was Carl Gommoll, MS, Forest Research Institute, Jersey City New Jersey, USA [APA 2014 (poster NR6\u2013103)].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EVLZ is a selective serotonin (5-HT) reuptake inhibitor and partial agonist of the 5-HT\u003Csub\u003E1A\u003C\/sub\u003E receptor. Two prior placebo-controlled Phase 3 trials reported the efficacy and safety of a 40-mg\/day dose [Khan A et al. \u003Cem\u003EJ Clin Psychiatry\u003C\/em\u003E 2011; Rickeis K et al. \u003Cem\u003EJ Clin Psychiatry\u003C\/em\u003E 2009]. Researchers of a 52-week open-label study reported the long-term safety and tolerability of the same dose [Robinson DS et al. \u003Cem\u003EJ Clin Psychopharmocol\u003C\/em\u003E 2011].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe current study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01473381\u0026amp;atom=%2Fspmdc%2F14%2F8%2F13.atom\u0022\u003ENCT01473381\u003C\/a\u003E] was conducted to confirm the results using this now-approved dose, as well as to assess the effectiveness, safety, and tolerability of a lower dose of 20 mg\/day. The study was placebo-controlled and incorporated Citalopram (CIT) 40 mg\/day as an active control for assay sensitivity. The study phases consisted of a 1- to 4-week drug-free screening period, 10-week double-blind treatment, and 1-week double-blind down-taper. The 1162 patients were randomly assigned 1:1:1:1 to receive placebo, VLZ 20 mg\/day, VLZ 40 mg\/day, or CIT 40 mg\/day, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIncluded patients were aged 18 to 70 years, met \u003Cem\u003EDSM-IV-TR\u003C\/em\u003E criteria for MDD and had ongoing major depressive episodes, had Montgomery-Asberg Depression Rating Scale (MADRS) total score \u226526 at screening and baseline, and were physically sound. Exclusion criteria included \u003Cem\u003EDSM-IV-TR\u003C\/em\u003E-defined Axis I disorder other than MDD within the prior 6 months (excepting secondary diagnoses of comorbid generalized anxiety disorder, social anxiety, and\/or specific phobia), defined suicide risk, absence of effect of \u22652 antidepressant drugs, and recent (within 2 weeks) use of psychoactive drugs or need for treatment with eszopiclone, zopiclone, or zaleplon.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary efficacy measure was MADRS total score. Secondary efficacy measures were Clinical Global Impressions-Severity (CGI-S) score and MADRS sustained response rate (\u226412 for at least the last two clinic visits during the treatment period). CGI-Improvement and Hamilton Rating Scale for Anxiety (HAM-A) scores were also determined. Safety outcomes were adverse events, patient-monitored parameters, and ratings of suicidal ideation and sexual functioning.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe safety population comprised 281 placebo, 288 VLZ 20mg, 287 VLZ 40 mg, and 282 CIT patients. Patient demographics were generally similar between the groups. Approximately 70% of patients completed the study. The rate of discontinuation was significantly higher in the VLZ 40-mg\/day group (34%) compared with the placebo (25%) group.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003ECompared with placebo, MADRS score improvement from baseline to Week 10 was significantly greater for VLZ 20 mg (least squares mean difference [LSMD], \u22122.57; adjusted p=0.0073) and VLZ 40 mg (LSMD, \u22122.82; adjusted p=0.0034) in the intent-to-treat population. CIT versus placebo had a similar pattern (LSMD, \u22122.74; p=0.0020), demonstrating assay sensitivity. In the same population, reductions in CGI-S scores were significantly greater than placebo for VLZ 20 mg (LSMD, \u22120.35; adjusted p=0.0073), VLZ 40 mg (LSMD,-0.33; adjusted p=0.0097), and CIT (LSMD, \u22120.35; p=0.0025). More patients met criteria for MADRS sustained response in the VLZ 20-mg (29.9%), VLZ 40-mg (33.5%), and CIT (31.1%) groups versus the placebo (26.3%) group; differences were not statistically significant.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EAll groups displayed similar adverse event (AE) profiles. Rates of treatment-emergent AEs (TEAEs) were similar for VLZ 20 mg (72.2%), VLZ 40 mg (77.4%), CIT (77.0%), and placebo (63.3%). TEAEs occurring in \u22655% of VLZ patients and twice placebo were diarrhea, nausea, vomiting, and insomnia. Majority of TEAEs were mild or moderate in severity. Serious AEs were reported in 2 placebo, 4 VLZ 20-mg, 4 VLZ 40-mg, and 6 CIT patients. One death occurred, in a patient receiving VLZ, which was not related to medication.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe data bolster support for the efficacy, safety, and tolerability of VLZ 40-mg\/day and indicate the utility of the 20-mg\/day dose.\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\/13.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?nzp80p\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}