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

Leslie Citrome, Carl P Gommoll, Xiongwen Tang, Rene Nunez, Maju Mathews, Leslie Citrome, Carl P Gommoll, Xiongwen Tang, Rene Nunez, Maju Mathews

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.

Figures

Fig. 1
Fig. 1
Treatment response and remission, odds ratios with 95% confidence intervals. CGI-S, Clinical Global Impressions-Severity; HAMA, Hamilton Rating Scale for Anxiety; MADRS, Montgomery-Åsberg Depression Rating Scale.
Fig. 2
Fig. 2
Rates of (a) response and (b) remission at study visits, on the basis of observed cases. The 95% confidence interval is not presented if the boundaries are not finite. **P<0.01; ***P<0.001 for vilazodone versus placebo. CI, confidence interval; MADRS, Montgomery–Åsberg Depression Rating; NA, not applicable (due to larger improvement in the placebo group); NNT, number needed to treat.

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