Objective: To evaluate the efficacy of vilazodone in achieving symptom remission in adults with major depressive disorder (MDD).
Methods: Post hoc analysis of a Phase IV, 8-week double-blind, fixed-dose study comparing vilazodone 40 mg/day with placebo. The primary efficacy outcome was change in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Secondary and additional efficacy outcomes included changes in Clinical Global Impressions-Severity (CGI-S) score and Hamilton Anxiety Rating Scale (HAMA) total score. Analyses were conducted to identify the percent of patients achieving depression symptom remission (MADRS≤10), complete remission (MADRS≤5), anxiety symptom remission (HAMA≤7), and combined depression/anxiety symptom remission (MADRS≤10 + HAMA≤7). Global disease remission was also assessed (CGI-S=1). Odds ratios (OR) and number needed to treat (NNT) were determined for these analyses.
Results: In the ITT population (placebo, n=252; vilazodone, n=253), MADRS remission rates were significantly higher with vilazodone versus placebo: remission (34% vs 22%; OR=1.82; P<.01; NNT=9); complete remission (18% vs 8%; OR=2.42; P<.01; NNT=11). Vilazodone-treated patients compared with placebo treated patients also had higher rates of anxiety symptom remission (49% vs 35%; P<.01; OR=1.82; NNT=8) and combined MADRS/HAMA remission (32% vs 20%; P<.01; OR=1.83; NNT=9). In addition, significantly more patients experienced global disease remission with vilazodone than with placebo: CGI-S (24% vs 12%; OR=2.41; P<.001; NNT=8).
Conclusions: These post hoc analyses suggest that vilazodone 40 mg/day is effective in achieving depression and anxiety symptom remission in adult patients with MDD.