Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder

Thase, Michael E.; Edwards, J.B.; Durgam, Suresh; Chen, Changzheng; Chang, Cheng‐Tao; Mathews, Maju; Gommoll, Carl

doi:10.1097/yic.0000000000000180

Cited by 10 publications

(3 citation statements)

References 25 publications

(43 reference statements)

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“…Pooled data for clinical trials of GAD and MDD showed that the incidences of suicidal ideation and behavior based on C-SSRS were similar or lower than placebo for vilazodone, a combined reuptake inhibitor and a 5-HT 1A receptor partial agonist approved for MDD in 2011. 46 The aforementioned studies agree with the meta-analyses of 207 randomized controlled trials of antidepressants and suicide-related events evaluated by the FDA. 14 Taken together, independent FDA analyses and data from various clinical trials suggest the safety of antidepressants and low risk of suicidal behavior in MDD patients taking antidepressants.…”

Section: Discussionsupporting

confidence: 79%

Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials

Mahableshwarkar¹,

Affinito

Reines

et al. 2019

CNS Spectr.

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ObjectivesThis study aimed to evaluate the risk of suicidal ideation and behavior associated with vortioxetine treatment in adults with major depressive disorder (MDD).MethodsSuicide-related events were evaluated post hoc using 2 study pools: one short-term pool of 10 randomized, placebo-controlled studies (6–8 weeks) and another long-term pool that included 3 open-label extension studies (52 weeks). Evaluation of suicide-related events was performed using Columbia-Suicide Severity Rating Scale (C-SSRS) scores and treatment-emergent adverse events (TEAEs) data.ResultsAt baseline, the percentage of patients reporting any C-SSRS ideation or behavior events in short-term studies was similar between placebo (14.7%), vortioxetine (19.8%, 13.0%, 11.2%, and 13.7% for 5-, 10-, 15-, and 20-mg groups, respectively), and duloxetine active reference (13.2%) and did not change throughout the 6- to 8-week treatment period for placebo (17.0%), vortioxetine (19.3%, 13.5%, 12.6%, and 15% for 5-, 10-, 15-, and 20-mg groups, respectively), or duloxetine (11.3%). The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine. After 52-week treatment with vortioxetine, suicidal ideation based on C-SSRS was 9.8%, C-SSRS suicidal behavior was 0.2%, and the incidence of suicide-related events based on TEAEs was <1%. There were no completed suicides in any study.ConclusionsVortioxetine is not associated with increased risk of suicidal ideation or behavior in MDD patients.

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Section: Discussionsupporting

confidence: 79%

Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials

Mahableshwarkar¹,

Affinito

Reines

et al. 2019

CNS Spectr.

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“…A pooled analysis of data from 8 clinical studies focused on the effects of vilazodone on measures of suicidal ideation, including treatment-emergent suicidality. 55 Among patients with suicidal ideation at baseline, a higher proportion of vilazodone-treated patients reported resolution of suicidal ideation during double-blind treatment than subjects who received placebo (39% to 45% vs 29% to 33%). Rates of treatment-emergent suicidal behaviors (eg, preparatory acts, aborted/interrupted attempts, attempted suicide) were similar between vilazodone and placebo (0.3–0.8% vs 0.1–0.7%).…”

Section: Clinical Efficacymentioning

confidence: 99%

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

Chauhan¹,

Parry²,

Bobo³

2022

NDT

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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.

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“…For example, a megaanalysis of adults receiving citalopram, paroxetine, sertraline, or placebo for major depression there was a significant decrease in the mean rating of suicidality on the Hamilton Rating Scale for Depression (HRSD) in subjects over 25 years old (Näslund et al, 2018). Numerous other studies also found reduction in suicidality, measured by varying rating scales, versus placebo or tricyclic antidepressants among adults taking SRIs (Beasley et al, 1991;Grunebaum et al, 2012;Gunnell et al, 2005;Hawton et al, 2015;Isacsson et al, 2009;Khan et al, 2018;Thase et al, 2017).…”

Section: Antidepressantsmentioning

confidence: 99%

Effects of somatic treatments on suicidal ideation and completed suicides

et al. 2021

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Objective: This work was undertaken to define and characterize the role of currently available somatic treatments in psychiatry in either increasing or reducing the risk for suicide.Methods: Members of the Suicide Prevention Task Group of the National Network of Depression Centers performed a literature review of somatic treatments known to increase or reduce the risk for suicide. The reviews ventured to include all relevant information about the risk for both suicide ideation and completed suicides.Results: Lithium and clozapine are the only two somatic treatments that have highquality data documenting their antisuicide effects in mood disorders and schizophrenia, respectively. Lithium discontinuation is also associated with increased suicide risk.Ketamine and esketamine may have a small, but immediate, antisuicide effect. Despite the recent Food and Drug Administration approval of esketamine use in depressed suicidal patients, the small disproportional overrepresentation of suicide in subjects who had received esketamine versus placebo (3 vs. 0 among > 3500 subjects) requires ongoing evaluation. The purported antisuicide effect of electroconvulsive therapy is based on low-quality data. The effect of antidepressants is not at all clear. There appears to be direct evidence for antidepressants increasing suicidal ideation and the risk for suicide over the short-term in young people, but indirect (low quality) evidence that antidepressants reduce suicide risk over the long term. Conclusions:Clinicians have an expanding pharmacopeia to address suicide potential in their patients. Some of the agents with documented antisuicide effects may also increase suicidality under specific circumstances.

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Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder

Cited by 10 publications

References 25 publications

Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials

Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials

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

Effects of somatic treatments on suicidal ideation and completed suicides

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