Evidence map›Paper›PMID 35356713›Full record

ArticleFrontiers in psychiatry2022

Effectiveness of Vortioxetine in Patients With Major Depressive Disorder in Real-World Clinical Practice: Results of the RELIEVE Study.

Gregory W Mattingly, Hongye Ren, Michael Cronquist Christensen, Martin A Katzman, Mircea Polosan, Kenneth Simonsen, Lene Hammer-Helmich

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03555136 (Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03555136 completednot on this map

Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

TypeobservationalSponsorH. Lundbeck A/SRan2017 to 2021Enrolled992ConditionsMajor Depressive DisorderArmsVortioxetine
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Gregory W MattinglySt Charles Psychiatric Associates & Midwest Research Group, St Charles, MO, United States.
Hongye RenMedical Affairs, H. Lundbeck A/S, Valby, Denmark.
Michael Cronquist ChristensenMedical Affairs, H. Lundbeck A/S, Valby, Denmark.
Martin A KatzmanSTART Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada.
Mircea PolosanUniv. Grenoble Alpes, Inserm, U1216, CHU de Grenoble Alpes, Grenoble Institut des Neurosciences (GIN), Grenoble, France.
Kenneth SimonsenMedical Affairs, H. Lundbeck A/S, Valby, Denmark.
Lene Hammer-HelmichMedical Affairs, H. Lundbeck A/S, Valby, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Randomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD). The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study was undertaken to demonstrate the effectiveness and safety of vortioxetine for the treatment of MDD in routine clinical practice. Methods: RELIEVE was a 24-week, observational, prospective cohort study in outpatients with MDD initiating treatment with vortioxetine at their physician's discretion in routine care settings in Canada, France, Italy, and the USA (NCT03555136). The primary study outcome was patient functioning assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity [9-item Patient Health Questionnaire (PHQ-9)], cognitive symptoms [5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5)], and cognitive performance [Digit Symbol Substitution Test (DSST)]. Mixed models of repeated measures were used to assess change from baseline at week 24, adjusted for relevant confounders. Results: A total of 737 patients were eligible for inclusion in the full analysis set. Most patients (73.7%) reported at least one comorbid medical condition, 56.0% had comorbid anxiety and 24.4% had comorbid generalized anxiety disorder. Improvement in least-squares (LS) mean SDS score from baseline to week 24 was 8.7 points. LS mean PHQ-9, PDQ-D-5 and DSST scores improved by 7.4, 4.6, and 6.2 points, respectively. Adverse events were observed in 21.2% of patients [most commonly, nausea (8.2% of patients)]. Conclusions: These results demonstrate the effectiveness and tolerability of vortioxetine for the treatment of MDD in a large and heterogeneous patient population representative of that encountered in routine clinical practice.

Indexed as

cognitive symptomseffectivenessfunctional recoveryfunctioningmajor depressive disorderobservational studyreal-world evidencevortioxetine

Identifiers

PMID35356713
PMCPMC8959350

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.