• Daniela Adamo, Giuseppe Pecoraro, Massimo Aria, Gianfranco Favia, and Michele Davide Mignogna.
• Departments of *Neurosciences, Reproductive and Odontostomatological Sciences.
• Pain Med. 2020 Jan 1; 21 (1): 185-194.

ObjectiveTo evaluate the efficacy of a new multimodal antidepressant, vortioxetine (VO), in the management of burning mouth syndrome (BMS).DesignLongitudinal single-assessment open-label pilot study.SettingUniversity hospital. Subjects. Thirty BMS patients were enrolled.MethodsBMS patients were treated with topical clonazepam and a flexible dose of VO (10 mg, 15 mg, or 20 mg). The visual analog scale (VAS), the Total Pain Rating Index (T-PRI), the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and the Pittsburgh Sleep Quality Index (PSQI) were performed at baseline (time 0) and after two (time 1), four (time 2), six (time 3), and 12 months (time 4) of treatment. Descriptive statistics and the Wilcoxon nonparametric test for two paired samples were used.ResultsThe BMS patients showed a statistically significant improvement in VAS and T-PRI scores from baseline (median [interquartile range {IQR}] = 10.0 [10-10] and 22.0 [20-24], respectively) to time 4 (median [IQR] = 0.0 [0-0] and 8.0 [7-9], P < 0.001, respectively). Similarly, the HAM-A and HAM-D and PSQI scores showed an improvement from time 0 (median [IQR] = 20 [15.8-22], 19 [16-20.3], and 4.0 [4-7.3], respectively) to time 4 (median [IQR] = 6.0 [6-7], 6.0 [6-7], and 3.0 [3-4], respectively, P < 0.001).ConclusionsVO is efficacious and well tolerated in the treatment of BMS in firstline therapy on account of its better receptor pharmacological profile and in second-line treatment for patients who have only partially responded or have reported adverse effects to previous treatments.© 2019 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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