Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder

Abstract

Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A partial agonist approved for major depressive disorder (MDD) treatment in adults. This was a 10-week, multicenter, double-blind, placebo-controlled and active-controlled, fixed-dose trial (NCT01473381). Adult patients with MDD (Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text revision criteria) were randomized 1 : 1 : 1 : 1 to vilazodone 20 or 40 mg/day, citalopram 40 mg/day, or placebo. Primary efficacy: Montgomery–Åsberg Depression Rating Scale (MADRS); secondary efficacy: Clinical Global Impressions-Severity and sustained response (MADRS total score≤12 for at least the last two consecutive double-blind visits). The intent-to-treat population comprised 1133 patients, (placebo=281; vilazodone 20 mg/day=288; vilazodone 40 mg/day=284; citalopram=280). MADRS and Clinical Global Impressions-Severity score change from baseline to week 10 was significantly greater for vilazodone 20 mg/day, vilazodone 40 mg/day, and citalopram versus placebo. Sustained response rates were numerically higher, but not significantly different, in all active treatment groups versus placebo. The most common adverse events (≥5% of vilazodone patients, twice the rate of placebo) were diarrhea, nausea, vomiting (vilazodone 40 mg/day only), and insomnia. Improved sexual function (Changes in Sexual Functioning Questionnaire scores) was seen in all groups; between-group differences were not significant. Vilazodone 20 and 40 mg/day demonstrated efficacy and tolerability in the treatment of MDD.

Variation in analytic transparency in recent efficacy studies of antidepressant medication

“…‘X’ indicates study coded positive for category; ‘– ’ indicates not applicable for that study.*Study: 1) Alvarez et al ,37 2012, 2) Baldwin et al ,38 2012, 3) Boulenger et al ,39 2014, 4) Croft et al ,40 2014, 5) Henigsberg et al ,41 2012, 6) Jacobsen et al ,42 2015, 7)Jain et al ,43 2013 8) Katona et al ,44 2012, 9)xKhan et al ,45 2011, 10) Mahableshwarker et al ,43 46 2013, 11) Mahableshwarker et al ,47 2015(a), 12) Mahableshwarker et al ,48 2015(b), 13) Mathews et al ,49 2015, 14) Montgomery et al ,50 2014, 15) Rickels et al ,51 2009, 16) Robinson et al ,52 2011, 17) Wang et al ,53 2015.ITT, intention to treat; LOCF, last observation carried forward; Vil, vilazodone; Vor, vortioxetine.…”

Association of 5-HT1A Receptors with Affective Disorders

“…In recent years, administration of vilazodone has shown antidepressant [75,76] and anxiolytic effects by eliminating physical and somatic symptoms in women with generalized anxiety disorder, after 8 weeks of treatment at daily doses of 20-40 mg [77,78]. This effect is due to the action mechanism of this SSRI, which is a partial agonist of postsynaptic 5-HT 1A receptors.…”

Efficacy and tolerability of vilazodone for major depressive disorder: evidence from phase III/IV randomized controlled trials

“…Moreover, vilazodone has also been proposed to control anxiety symptoms 11. Thus far, two phase III12,13 and two phase IV14,15 double-blind, placebo-controlled trials have explored the efficacy and tolerability of vilazodone for adult patients with MDD. Vilazodone (40 mg) was found to significantly improve depressive symptoms during short-term (8 or 10 weeks) treatment of MDD.…”

“…Vilazodone (40 mg) was found to significantly improve depressive symptoms during short-term (8 or 10 weeks) treatment of MDD. However, nausea, diarrhea, insomnia, dizziness, headache, dry mouth, and fatigue were commonly reported in clinical trials 12–15. In addition, several studies reported that vilazodone might have a potential anxiolytic-like effect 12–15…”