A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder*

Jain, Rakesh K.; Mahableshwarkar, Atul R.; Jacobsen, Paula; Chen, Yinzhong; Thase, Michael E.

doi:10.1017/s1461145712000727

Cited by 116 publications

(126 citation statements)

References 24 publications

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“…In the current analysis, functional remission (SDS total score ≤6) at week 6/8 was 25.5%, 30.4%, 30.9%, and 31.2% for vortioxetine 5, 10, 15, and 20 mg, respectively. Symptomatic remission rates (MADRS total score ≤10) at these doses in the individual studies ranged from 28.8% to 36.0% for vortioxetine 5 mg, 21.4%–36.0% for vortioxetine 10 mg, 23.9%–34.9% for vortioxetine 15 mg, and 29.3%–38.4% for vortioxetine 20 mg, respectively (Baldwin et al., 2012; Boulenger et al., 2014; Henigsberg et al., 2012; Jacobsen et al., 2015; Jain et al., 2013; Mahableshwarkar, Jacobsen, Chen, et al., 2015; Mahableshwarkar, Jacobsen, Serenko, et al., 2015; Mahableshwarkar et al., 2013). …”

Section: Discussionmentioning

confidence: 99%

“…Additionally, vortioxetine 10 mg daily demonstrated clinically significant benefits on all aspects of functioning (SDS single‐item scores) in the total population as well as on overall functioning (SDS total score) in patients with severe MDD and/or significant functional impairment or high anxiety symptoms at baseline. These findings are consistent with the results of the individual studies, where vortioxetine administration was associated with improvements in patient functioning as well as in depressive symptoms (Baldwin et al., 2012; Boulenger et al., 2014; Henigsberg et al., 2012; Jacobsen et al., 2015; Jain et al., 2013; Mahableshwarkar, Jacobsen, Chen, et al., 2015; Mahableshwarkar, Jacobsen, Serenko, et al., 2015; Mahableshwarkar et al., 2013; Takeda, 2013). …”

Section: Discussionmentioning

confidence: 99%

“…Thus, data from nine short‐term (6/8 weeks) multicenter, double‐blind, randomized, placebo‐controlled, parallel‐group, fixed‐dose clinical studies of vortioxetine conducted in adults (aged 18–75 years) with MDD were analyzed. The details of the study design and the results of the nine included trials have been previously published (Baldwin et al., 2012; Boulenger et al., 2014; Henigsberg et al., 2012; Jacobsen et al., 2015; Jain et al., 2013; Mahableshwarkar, Jacobsen, Chen, et al., 2015; Mahableshwarkar, Jacobsen, Serenko, et al., 2015; Mahableshwarkar et al., 2013; Takeda, 2013). Table 1 provides a summary of treatment dosages, number of participants in each dosage arm, treatment duration, and key inclusion criteria for each of the trials included in this meta‐analysis.…”

Section: Methodsmentioning

confidence: 99%

“…All patients enrolled in these studies met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM‐IV‐TR; American Psychiatric Association (APA), 2000) criteria for a major depressive episode lasting ≥3 months and were ≥18 years old. Additionally, patients were required to have Montgomery‐Åsberg Depression Rating Scale (MADRS; Montgomery & Asberg, 1979) scores ≥22 (NCT00672620, Mahableshwarkar et al., 2013), ≥30 (NCT00672958, Jain et al., 2013) or ≥26 (all other trials; Baldwin et al., 2012; Boulenger et al., 2014; Henigsberg et al., 2012; Jacobsen et al., 2015; Mahableshwarkar, Jacobsen, Chen, et al., 2015; Mahableshwarkar, Jacobsen, Serenko, et al., 2015; Takeda, 2013; Table 1). …”

Section: Methodsmentioning

confidence: 99%

“…The efficacy and safety of vortioxetine in patients with MDD has been demonstrated in a series of short‐ and long‐term studies (Alvarez et al., 2012; Boulenger, Loft, & Olsen, 2014; Henigsberg et al., 2012; Jacobsen et al., 2015; Katona, Hansen, & Olsen, 2012; Mahableshwarkar, Jacobsen, Chen, et al., 2015; McIntyre, Lophaven, & Olsen, 2014; Montgomery, Nielsen, et al., 2014). The effects of vortioxetine on general functioning were assessed (with the SDS) as secondary measures in a subset of short‐term clinical trials (Baldwin, Loft, & Dragheim, 2012; Boulenger et al., 2014; Henigsberg et al., 2012; Jacobsen et al., 2015; Jain et al., 2013; Mahableshwarkar, Jacobsen, & Chen, 2013; Mahableshwarkar, Jacobsen, Chen, et al., 2015; Mahableshwarkar, Jacobsen, Serenko, et al., 2015; Takeda, 2013). The purpose of this post hoc meta‐analysis was to analyze the SDS results from these studies to determine the effect of vortioxetine on overall patient functioning as well as the proportion of patients who achieved functional remission versus placebo.…”

Section: Introductionmentioning

confidence: 99%

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The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

et al. 2017

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BackgroundThe objectives of this meta‐analysis of data from randomized, placebo‐controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD).MethodsData from nine short‐term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random‐effects meta‐analysis, which used aggregated study‐level data for all therapeutic vortioxetine doses and a mixed‐effect model for repeated measures using the full analysis set.ResultsA total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5–20 mg/day). At study end, the meta‐analysis showed improvement for vortioxetine versus placebo (n = 911) in SDS total score (vortioxetine 5 mg, n = 564, change from baseline versus placebo [Δ] −0.24, p = NS; 10 mg, n = 445, Δ −1.68, p ≤ .001; 15 mg, n = 204, Δ −0.91, p = NS; 20 mg, n = 340, Δ −1.94, p ≤ .01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n = 170/573; odds ratio [OR] relative to placebo 1.7, p < .001) and 20 mg (n = 144/447; OR 1.6, p < .05), but not 5 mg (n = 207/757; OR 1.1, p = NS) or 15 mg (n = 92/295; OR 1.3, p = NS).ConclusionVortioxetine 5–20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

et al. 2017

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Differential Outcomes of Placebo Treatment Across 9 Psychiatric Disorders

Bschor,

Nagel,

Unger

et al. 2024

JAMA Psychiatry

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ImportancePlacebo is the only substance systematically evaluated across common psychiatric diagnoses, but comprehensive cross-diagnostic comparisons are lacking.ObjectiveTo compare changes in placebo groups in recent high-quality randomized clinical trials (RCTs) across a broad spectrum of psychiatric disorders in adult patients.Data SourcesMEDLINE and the Cochrane Database of Systematic Reviews were systematically searched in March 2022 for the latest systematic reviews meeting predetermined high-quality criteria for 9 major psychiatric diagnoses.Study SelectionUsing these reviews, the top 10 highest-quality (ie, lowest risk of bias, according to the Cochrane Risk of Bias tool) and most recent placebo-controlled RCTs per diagnosis (totaling 90 RCTs) were selected, adhering to predetermined inclusion and exclusion criteria.Data Extraction and SynthesisFollowing the Cochrane Handbook, 2 authors independently carried out the study search, selection, and data extraction. Cross-diagnosis comparisons were based on standardized pre-post effect sizes (mean change divided by its SD) for each placebo group. This study is reported following the Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guideline.Main Outcome and MeasureThe primary outcome, pooled pre-post placebo effect sizes (dav) with 95% CIs per diagnosis, was determined using random-effects meta-analyses. A Q test assessed statistical significance of differences across diagnoses. Heterogeneity and small-study effects were evaluated as appropriate.ResultsA total of 90 RCTs with 9985 placebo-treated participants were included. Symptom severity improved with placebo in all diagnoses. Pooled pre-post placebo effect sizes differed across diagnoses (Q = 88.5; df = 8; P &lt; .001), with major depressive disorder (dav = 1.40; 95% CI, 1.24-1.56) and generalized anxiety disorder (dav = 1.23; 95% CI, 1.06-1.41) exhibiting the largest dav. Panic disorder, attention-deficit/hyperactivity disorder, posttraumatic stress disorder, social phobia, and mania showed dav between 0.68 and 0.92, followed by OCD (dav = 0.65; 95% CI, 0.51-0.78) and schizophrenia (dav = 0.59; 95% CI, 0.41-0.76).Conclusion and RelevanceThis systematic review and meta-analysis found that symptom improvement with placebo treatment was substantial in all conditions but varied across the 9 included diagnoses. These findings may help in assessing the necessity and ethical justification of placebo controls, in evaluating treatment effects in uncontrolled studies, and in guiding patients in treatment decisions. These findings likely encompass the true placebo effect, natural disease course, and nonspecific effects.

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Vortioxetine for depression in adults

Koesters

Ostuzzi

Guaiana

et al. 2017

Cochrane Database of Systematic Reviews

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The place of vortioxetine in the treatment of acute depression is unclear. Our analyses showed vortioxetine may be more effective than placebo in terms of response, remission and depressive symptoms, but the clinical relevance of these effects is uncertain. Furthermore, the quality of evidence to support these findings was generally low. In comparison to SNRIs, we found no advantage for vortioxetine. Vortioxetine was less effective than duloxetine, but fewer people reported adverse effects when treated with vortioxetine compared to duloxetine. However, these findings are uncertain and not well supported by evidence. A major limitation of the current evidence is the lack of comparisons with the SSRIs, which are usually recommended as first-line treatments for acute depression. Studies with direct comparisons to SSRIs are needed to address this gap and may be supplemented by network meta-analyses to define the role of vortioxetine in the treatment of depression.

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A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder*

Cited by 116 publications

References 24 publications

The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

Differential Outcomes of Placebo Treatment Across 9 Psychiatric Disorders

Vortioxetine for depression in adults

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