Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome

Summary

Background: The treatment of Burning Mouth Syndrome (BMS) presents a challenge in tailoring appropriate medication for individual patients. Antidepressants have demonstrated efficacy in alleviating symptoms in most cases; however, a subset of patients exhibit limited or no response to these treatments. The augmentation with pregabalin to conventional treatment has shown promising outcomes in relieving pain and improving 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 using clinical data. Methods: A 52-week randomized, open-label, active-controlled study was conducted, enrolling 203 BMS patients previously treated with one antidepressant for 12 weeks and non-responder to the treatment. The study sample have included two groups: Group A (136) received vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75mg/day) was added to both groups, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks. Treatment response was assessed by measuring reduction in VAS and SF-MPQ scores (\>50 or 1-2) and HAM-A and HAM-D scores (\>50% or ≤7) at 12, 24, 36 and 52 weeks. Classical logistic regression with a stepwise algorithm and Random Forest machine learning models were used to predict treatment response.

Timeline

Start

2023-01-01

Primary completion

2023-10-30

Completion

2024-07-24

Publications

• Background Adamo D, Calabria E, Coppola N, Pecoraro G, Mignogna MD. Vortioxetine as a new frontier in the treatment of chronic neuropathic pain: a review and update. Ther Adv Psychopharmacol. 2021 Sep 3;11:20451253211034320. doi: 10.1177/20451253211034320. eCollection 2021.
• Background Adamo D, Pecoraro G, Coppola N, Calabria E, Aria M, Mignogna M. Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial. Oral Dis. 2021 May;27(4):1022-1041. doi: 10.1111/odi.13602. Epub 2020 Sep 15.
• Adamo D, Canfora F, Pecoraro G, Leuci S, Coppola N, Marenzi G, Ottaviani G, Rupel K, Pellegrini L, Aria M, D'Aniello L, Mignogna MD, Albert U. Vortioxetine versus SSRI/SNRI with Pregabalin Augmentation in Treatment-Resistant Burning Mouth Syndrome: A Prospective Clinical Trial. Curr Neuropharmacol. 2025;23(7):800-819. doi: 10.2174/1570159X22999240729103717.

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