Vortioxetine in the Treatment of Mood Disorders Associated with Burning Mouth Syndrome: Results of an Open-Label, Flexible-Dose Pilot Study

Objective To evaluate the efficacy of a new multimodal antidepressant, vortioxetine (VO), in the management of burning mouth syndrome (BMS). Design Longitudinal single-assessment open-label pilot study. Setting University hospital. Subjects. Thirty BMS patients were enrolled. Methods BMS 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. Results The 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). Conclusions VO 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.