Vilazodone Efficacy Across Somatic and Psychic Symptoms of Depression: A Pooled Analysis From 4 Randomized and Placebo-Controlled Studies

Background: Vilazodone (VLZ) is a serotonin reuptake inhibitor and 5-HT1A receptor partial agonist approved for the treatment of Major Depressive Disorder (MDD). Historically, MDD studies assess efficacy as mean reductions in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline. However, clinicians can benefit from patient-centric analyses to make informed treatment decisions. The current post-hoc analysis provides additional assessments of VLZ’s ability to improve MDD symptoms.

Methods: A post-hoc analysis was conducted utilizing pooled data from 4 double-blind, placebo-controlled studies of nearly 2000 adult patients with MDD treated with VLZ 40 mg/day (N=970) or placebo (N=966) for 8 weeks. These analyses evaluated the effects of VLZ versus PBO treatment on the distribution of MADRS total score changes and on individual MADRS items that measure somatic and psychic symptoms.

Results: Distribution of MADRS total score changes from baseline to week 8 demonstrate that more patients treated with VLZ 40 mg/day (57.3%) experienced improvements of ≥16 points compared with placebo (44.7%). Conversely, more PBO patients experienced no change or a worsening of MADRS total scores compared with VLZ (12.2% and 8.9%, respectively). Lastly, patients treated with VLZ demonstrated significant improvements in all 10 MADRS items compared with PBO.

Conclusion: Aside from the customary measures used to gain regulatory approval, there are other - more patient-centric ones that can help guide antidepressant treatment decisions. The present results, coupled with greater response and remission rates with VLZ reported earlier, suggest it’s a suitable first treatment option for patients with MDD.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.