NYMC Faculty Publications

Evaluating the Efficacy of Vilazodone in Achieving Remission in Patients With Major Depressive Disorder: Post-Hoc Analyses of a Phase IV Trial

Author Type(s)

Faculty

DOI

10.1097/YIC.0000000000000056

Journal Title

International Clinical Psychopharmacology

First Page

75

Last Page

81

Document Type

Article

Publication Date

3-1-2015

Department

Psychiatry and Behavioral Sciences

Keywords

Adolescent, Adult, Antidepressive Agents, Benzofurans, Major Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Indoles, Male, Middle Aged, Models, Statistical, Piperazines, Psychiatric Status Rating Scales, Remission Induction, Symptom Assessment, Vilazodone Hydrochloride, Young Adult

Disciplines

Medicine and Health Sciences

Abstract

The aim of this study was to evaluate the efficacy of vilazodone using different definitions of remission. Post-hoc analyses were carried out using data from an 8-week, multicenter, randomized, double-blind, placebo-controlled trial of vilazodone 40 mg/day in adults with major depressive disorder (NCT01473394). The primary efficacy endpoint was a mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score; additional measures included the Clinical Global Impressions-Severity (CGI-S) and Hamilton Rating Scale for Anxiety (HAMA) scores. In addition to treatment response (MADRS≥50% improvement), post-hoc analyses were carried out for remission of depressive symptoms [MADRS score≤10; MADRS≤5 (complete remission)], anxiety symptoms (HAMA≤7), and combined depression and anxiety symptoms (MADRS/HAMA≤10/≤7), as well as for overall symptom severity (CGI-S=1). Odds ratios (ORs) and numbers needed to treat (NNTs) were also calculated. Significant outcomes were obtained with vilazodone versus placebo for MADRS response (50.6 vs. 33.3%, OR=2.04, P< 0.001, NNT=6), remission (34.0 vs. 21.8%, OR=1.82, P=0.003, NNT=9), and complete remission (18.2 vs. 8.3%, OR=2.42, P=0.002, NNT=11). More patients receiving vilazodone rather than placebo also met remission criteria for HAMA (48.8 vs. 35.2%, OR=1.82, P=0.002, NNT=8), MADRS/HAMA (32.1 vs. 20.4%, OR=1.83, P=0.004, NNT=9), and CGI-S (24.1 vs. 11.5%, OR=2.41, P< 0.001, NNT=8). Treatment with vilazodone 40 mg/day may help adult patients with major depressive disorder achieve remission of depression and/or anxiety symptoms.

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