Evidence map›Paper›PMID 25687662›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2015

A Randomized, Placebo-Controlled, Active-Reference, Double-Blind, Flexible-Dose Study of the Efficacy of Vortioxetine on Cognitive Function in Major Depressive Disorder.

Atul R Mahableshwarkar, John Zajecka, William Jacobson, Yinzhong Chen, Richard S E Keefe

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 124 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed, 11 pooled it
32.9field-weighted citation impact, top 1% of its field
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.

NCT02528409 phase2completednot on this mapstarted 2016, after this paper: background citation

A Double-Blind, Placebo-Controlled Study of Vortioxetine in the Treatment of Binge Eating Disorder

TypeinterventionalSponsorUniversity of ChicagoRan2016 to 2018Enrolled80ConditionsBinge Eating DisorderArmsVortioxetine, Placebo
NCT05047952 phase2completednot on this mapstarted 2021, after this paper: background citation

Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Vortioxetine for Cognitive Deficits in Persons With Post-COVID-19 Condition

TypeinterventionalSponsorBrain and Cognition Discovery FoundationRan2021 to 2023Enrolled149ConditionsPost-COVID-19 Condition, Post-COVID-19 Syndrome, Cognitive ImpairmentArmsVortioxetine, Placebo
3 · Its place in the literature

Who cites it

124 citing papers in PubMed, 11 syntheses or guidelines pooled it, 305 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Efficacy of vortioxetine on the physical symptoms of major depressive disorder.Journal of psychopharmacology (Oxford, England) · 2018
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Vortioxetine for depression in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Trial
  13. Combined Cognitive Training and Vortioxetine Mitigates Age-Related Declines in Functional Brain Network Integrity.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2023
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

64 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Atul R MahableshwarkarTakeda Development Center Americas, Deerfield, IL, USA.
John ZajeckaDepartment of Psychiatry, Rush University Medical Center, Chicago, IL, USA.
William JacobsonTakeda Development Center Americas, Deerfield, IL, USA.
Yinzhong ChenTakeda Development Center Americas, Deerfield, IL, USA.
Richard S E KeefeDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
Takeda (United States) · USDeerfield (United States) · USDuke University Hospital · USRush University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter, randomized, double-blind, placebo-controlled, active-referenced (duloxetine 60 mg), parallel-group study evaluated the short-term efficacy and safety of vortioxetine (10-20 mg) on cognitive function in adults (aged 18-65 years) diagnosed with major depressive disorder (MDD) who self-reported cognitive dysfunction. Efficacy was evaluated using ANCOVA for the change from baseline to week 8 in the digit symbol substitution test (DSST)-number of correct symbols as the prespecified primary end point. The patient-reported perceived deficits questionnaire (PDQ) and physician-assessed clinical global impression (CGI) were analyzed in a prespecified hierarchical testing sequence as key secondary end points. Additional predefined end points included the objective performance-based University of San Diego performance-based skills assessment (UPSA) (ANCOVA) to measure functionality, MADRS (MMRM) to assess efficacy in depression, and a prespecified multiple regression analysis (path analysis) to calculate direct vs indirect effects of vortioxetine on cognitive function. Safety and tolerability were assessed at all visits. Vortioxetine was statistically superior to placebo on the DSST (P < 0.05), PDQ (P < 0.01), CGI-I (P < 0.001), MADRS (P < 0.05), and UPSA (P < 0.001). Path analysis indicated that vortioxetine's cognitive benefit was primarily a direct treatment effect rather than due to alleviation of depressive symptoms. Duloxetine was not significantly different from placebo on the DSST or UPSA, but was superior to placebo on the PDQ, CGI-I, and MADRS. Common adverse events (incidence ⩾ 5%) for vortioxetine were nausea, headache, and diarrhea. In this study of MDD adults who self-reported cognitive dysfunction, vortioxetine significantly improved cognitive function, depression, and functionality and was generally well tolerated.

Indexed as

AdolescentAdultAgedAnti-Anxiety AgentsCognition DisordersDose-Response Relationship, DrugDouble-Blind MethodDuloxetine HydrochlorideFemaleFollow-Up StudiesHumansMajor Depressive DisorderMaleMiddle AgedNeuropsychological TestsPiperazinesAnti-Anxiety AgentsDuloxetine HydrochloridePiperazinesSulfidesVortioxetine

Identifiers

PMID25687662
PMCPMC4839526
OpenAlexW1967366594

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.