Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial.

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.

• Authors: Leslie Citrome, Carl P Gommoll, Xiongwen Tang, Rene Nunez, Maju Mathews
• Journal: International clinical psychopharmacology (Int Clin Psychopharmacol) Vol. 30 Issue 2 Pg. 75-81 (Mar 2015) ISSN: 1473-5857 [Electronic] England
• PMID: 25396353 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antidepressive Agents
• Benzofurans
• Indoles
• Piperazines
• Vilazodone Hydrochloride

Topics

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