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Review
. 2022 Jun 14:18:1175-1193.
doi: 10.2147/NDT.S279342. eCollection 2022.

Vilazodone for Major Depression in Adults: Pharmacological Profile and an Updated Review for Clinical Practice

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Review

Vilazodone for Major Depression in Adults: Pharmacological Profile and an Updated Review for Clinical Practice

Mohit Chauhan et al. Neuropsychiatr Dis Treat. .

Abstract

This article provides an updated review of the pharmacological profile and available efficacy and tolerability/safety data for vilazodone, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults. The efficacy of vilazodone for MDD in adults is supported by four positive short-term (8-10 weeks), randomized, placebo-controlled trials. Beyond these pivotal trials, we review updated research findings pertaining to the clinical effects of vilazodone for MDD including the results of switch studies, small comparative efficacy trials, key pooled and secondary data analyses focused on important depressive subtypes (anxious depression) and predictors of treatment outcome, and safety studies including direct studies of sexual side-effects. Despite these additional research efforts and use for over a decade, important gaps in the clinical evidence base remain with vilazodone. Hypothesized differences in efficacy and adverse effects between other antidepressants and vilazodone based on its multimodal mechanism of action (combining serotonin reuptake inhibition with serotonin 5-HT1A partial agonist effects) have not been comprehensively demonstrated in clinical studies and its effectiveness as a continuation- or maintenance-phase therapeutic is not yet established. Questions remain regarding its reproductive and lactational safety profiles and its efficacy as a potential next-step therapeutic for patients with MDD who do not respond to first-line antidepressants such as selective serotonin reuptake inhibitors. Suggestions for clinical use of vilazodone and discussion of its place among the broad range of pharmacotherapies for adults with MDD are provided.

Keywords: comparative effectiveness; depression; efficacy; major depressive disorder; safety; vilazodone.

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Conflict of interest statement

WVB’s research has been supported by NIMH, AHRQ, NSF, the Mayo Foundation for Medical Education and Research, and the Myocarditis Foundation. WVB has contributed chapters to UpToDate regarding the pharmacological treatment of adults with bipolar major depression. The remaining authors report no conflicts of interest.

Figures

Figure 1
Figure 1
Estimated risk of bias of short-term randomized trials of vilazodone for major depressive disorder in adults. This figure provides a summary of an assessment of overall risk of bias across four published studies of vilazodone for treating major depressive disorder in adults, using the Cochrane Risk of Bias Assessment tool.
Figure 2
Figure 2
Frequency of selected adverse effects based on pooled data from short-term trials of vilazodone for major depressive disorder (MDD) in adults. This graph displays the pooled frequencies of selected treatment-emergent adverse effects with vilazodone 40 mg/day (n=436) and placebo (n=433) using data from two 8-week randomized phase III trials of vilazodone for MDD in adults. Each ring in the graph represents the frequency of specified treatment-emergent adverse effects (TEAEs), ranging from 0% (at the center) to 30% (at the outer edge). Only selected adverse effects that occurred in ≥ 5% of patients randomized to either vilazodone or placebo are shown.
Figure 3
Figure 3
Frequency of selected adverse effects on sexual functioning, based on pooled data from short-term randomized trials of vilazodone for major depressive disorder in adults. This graph displays the pooled sex-specific frequencies of treatment-emergent adverse effects (TEAEs) with vilazodone (n=197) and placebo (n=198) on sexual performance by spontaneous self-report. Each ring in the graph represents the frequency of specified treatment-emergent adverse effects (TEAEs), ranging from 0% (at the center) to 14% (at the outer edge). * Erectile dysfunction is reported for men only.

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