A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder

Boulenger, Jean‐Philippe; Loft, Henrik; Florea, Ioana

doi:10.1177/0269881112441866

Cited by 114 publications

(92 citation statements)

References 19 publications

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“…Boulenger et al conducted a placebo-controlled, double-blind, fixed-dose study to evaluate the efficacy of vortioxetine in the prevention of MDD relapse [27]. Patients recruited from 17 countries were eligible if they had a current MDE with moderate to severe depression at baseline (MADRS score ‡ 26).…”

Section: Efficacy Results --Mdd --Affective Symptomatologymentioning

confidence: 99%

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Vortioxetine: a review of efficacy, safety and tolerability with a focus on cognitive symptoms in major depressive disorder

Al-Sukhni

Maruschak

McIntyre

2015

Expert Opinion on Drug Safety

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Section: Efficacy Results --Mdd --Affective Symptomatologymentioning

confidence: 99%

“…Based on positron [19][20][21][22][23][24][25][26][27][28][29][30][31]37,38] Pharmaprojects --copyright to Citeline Drug Intelligence (an Informa business). Readers are referred to Pipeline (http://informa-pipeline.citeline.com) and Citeline (http://informa.citeline.com).…”

Section: Serotonin Transporter Occupancymentioning

confidence: 99%

Vortioxetine: a review of efficacy, safety and tolerability with a focus on cognitive symptoms in major depressive disorder

Al-Sukhni

Maruschak

McIntyre

2015

Expert Opinion on Drug Safety

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“…In order to establish whether any additional benefit of vortioxetine in working patients with MDD would be isolated to cognitive performance or whether it was broader to also encompass an antidepressant effect, data on antidepressant response in working patients from 3 additional short-term, randomized, placebo-controlled studies [18][19][20] and data on the risk of relapse in 1 relapse prevention study in MDD 21 (all of which included the HEA) were also considered (ClinicalTrials identifiers: NCT00635219, 18 NCT00735709,…”

Section: Study Population For Investigation Of Effect On Depressive Smentioning

confidence: 99%

“…A total of 2,206 patients were included in the full analysis set from the 4 short-term clinical studies, [18][19][20][21] excluding patients treated with nontherapeutic doses of vortioxetine (1 and 2.5 mg). The relapse prevention study included 396 patients randomized after open-label treatment.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

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Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder

McIntyre¹,

Florea²,

Tonnoir³

et al. 2016

J. Clin. Psychiatry

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Objective: This post hoc analysis investigates the effect of vortioxetine on cognitive functioning and depressive symptoms in working adults with major depressive disorder (MDD).Methods: Population data from FOCUS, a double-blind, randomized, placebo-controlled study investigating the efficacy of vortioxetine versus placebo on cognitive functioning and depression in patients with MDD, were used to analyze mean change from baseline scores for the Digit Symbol Substitution Test (DSST), Trail Making Test A/B (TMT-A/B), Stroop, and Perceived Deficits Questionnaire (PDQ). FOCUS, conducted from December 2011 through May 2013, included adult patients with recurrent MDD according to DSM-IV-TR criteria. Change in depression severity (Montgomery-Asberg Depression Rating Scale [MADRS] total score) was analyzed using data from 3 additional short-term placebo-controlled studies (2 of which included duloxetine) and 1 relapse prevention study. Analyses were done according to patients' working status at baseline and workplace position. All analyses were made versus placebo. Results:In FOCUS, the effect versus placebo on the DSST was 5.6 for 10 mg and 5.0 for 20 mg (P < .001 for both doses) in working patients; the effect was 4.0 (P < .001 for both doses) in total study population. The effect remained significant when adjusting for change in MADRS. In patients with "professional" positions, the effect was 9.2 for 10 mg (P = .006) and 9.0 for 20 mg (P = .001). A similar pattern of results was also observed for TMT-A/B, Stroop, PDQ, and MADRS total score. The efficacy of duloxetine was not different in working patients (MADRS). Conclusions:The beneficial effects of vortioxetine on objective and subjective measures of cognitive functioning are greater in working patients with MDD; the observed benefits were independent of improvement in depressive symptoms. 6 Evidence indicates that among adults with MDD, cognitive symptoms account for more variability in workplace performance than does total depressive symptom severity. 7 These observations support research underscoring the notion that cognitive dysfunction is a critical mediator of role impairment in MDD. 8Results from 2 double-blind, randomized, placebo-controlled studies demonstrated a clinical benefit of vortioxetine on cognitive functioning in adults with MDD, including objective neuropsychological tests of executive functioning, speed of processing, verbal learning, and memory.9-11 These studies confirm and extend the results from an earlier double-blind, randomized, placebo-controlled, duloxetine-referenced study with vortioxetine in elderly (≥ 65 years) patients with MDD. 12The beneficial effect observed on measures of cognitive functioning with vortioxetine is of particular importance for individuals with MDD who are working and/or engaged in activities that place high demands on cognition (eg, educational pursuit). Because depression is primarily a disorder affecting people of working age, 13 it is important to understand how the effect of vortioxetine on cognit...

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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 clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder

Cited by 114 publications

References 19 publications

Vortioxetine: a review of efficacy, safety and tolerability with a focus on cognitive symptoms in major depressive disorder

Vortioxetine: a review of efficacy, safety and tolerability with a focus on cognitive symptoms in major depressive disorder

Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder

Vortioxetine for depression in adults

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