Evidence map›Paper›PMID 40016875›Full record

Trial reportCurrent neuropharmacology2025

Vortioxetine

Daniela Adamo, Federica Canfora, Giuseppe Pecoraro, Stefania Leuci, Noemi Coppola, Gaetano Marenzi, Giulia Ottaviani, Katia Rupel, Luca Pellegrini, Massimo Aria and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Current neuropharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06025474 (Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT06025474 phase3unknown statusnot on this map

Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome: a Prospective Longitudinal Clinical Trial With Treatment Response Prediction

TypeinterventionalSponsorFederico II UniversityRan2023 to 2024Enrolled203ConditionsBurning Mouth SyndromeArmsVortioxetine 20Mg Tab, Paroxetine 20 Mg Oral Tablet, Sertraline 50 MG, Citalopram 20mg, Escitalopram 10mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Management strategies for burning mouth syndrome: a comprehensive review.Journal of oral & facial pain and headache · 2026
    Review
  4. Article
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

13 authors.

Daniela AdamoDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Federica CanforaDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Giuseppe PecoraroDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Stefania LeuciDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Noemi CoppolaDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Gaetano MarenziDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Giulia OttavianiDepartment of Surgical, Medical and Health Sciences, University of Trieste, 447 Strada di Fiume, 34149, Trieste, Italy.
Katia RupelDepartment of Surgical, Medical and Health Sciences, University of Trieste, 447 Strada di Fiume, 34149, Trieste, Italy.
Luca PellegriniDepartment of Biomedical and Neuromotor Sciences, University of Bologna, Viale Carlo Pepoli, 5, 40123, Bologna (BO), Italy.
Massimo AriaDepartment of Economics and Statistics, University of Naples Federico II, 21 Via Cintia, 80126, Naples, Italy.
Luca D'AnielloDepartment of Social Sciences, University of Naples Federico II, 1 Vico Monte della Pietà, 80138, Naples, Italy.
Michele Davide MignognaDepartment of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 5 Via Pansini, 80131, Naples, Italy.
Umberto AlbertDepartment of Surgical, Medical and Health Sciences, University of Trieste, 447 Strada di Fiume, 34149, Trieste, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe treatment of Burning Mouth Syndrome (BMS) represents a challenge in tailoring appropriate medication for individual patients. The augmentation of pregabalin to conventional treatment has shown promising outcomes in relieving pain and improving the quality of life in chronic pain conditions. This study aimed to compare the efficacy of vortioxetine with other antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS patients and to predict treatment response by using clinical data.

methodsA 52-week randomized, open-label, comparative clinical study was conducted, enrolling 203 BMS patients previously treated with one antidepressant for 12 weeks and non-responders to the treatment (clinical trial registration: NCT06025474). The study sample included two groups: Group A (136) received vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75 mg/day) was added to both groups, with a potential dosage increase to 150 mg/day for inadequate responders after 12 weeks. Treatment response was assessed with VAS and SF-MPQ, HAM-A, and HAM-D scores at 12, 24, 36, and 52 weeks. Stepwise logistic regression analysis was used to predict treatment response.

resultsA total of 84 (61.8%) BMS patients in Group A and 39 (58.2%) in Group B showed treatment response. Group A reported a faster onset of action compared to Group B (44.8% versus 22.4% at time 1; p:0.002**) and lower adverse event rates (8.8% versus 20.8%; p:0.001).

conclusionThe addition of pregabalin to vortioxetine may be considered a potential treatment option for BMS. Further research is required to corroborate these findings and optimize personalized treatment approaches for BMS patients. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT06025474).

Indexed as

Burning Mouth SyndromePregabalinSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake InhibitorsVortioxetineAdultAgedDrug Therapy, CombinationFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomePregabalinSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake InhibitorsVortioxetineanxietyBurning mouth syndromedepression.painpregabalinvortioxetine

Identifiers

PMID40016875
PMCPMC12163466

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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.