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

Launched by FEDERICO II UNIVERSITY · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called vortioxetine compared to other common antidepressants in treating Burning Mouth Syndrome (BMS), a condition where people experience a burning sensation in their mouths without a clear medical cause. The researchers are looking to see if adding another medication called pregabalin, which can help with pain, can improve the outcomes for patients who haven't responded to their previous antidepressant treatment. The trial will involve 203 participants who have been diagnosed with BMS and have not found relief after taking one antidepressant for at least 12 weeks.

To qualify for the study, participants must be adults aged between 65 and 74, have been experiencing daily oral burning for more than three months, and have normal blood test results. They should also have previously tried one antidepressant without success. During the trial, participants will receive either vortioxetine or another antidepressant, along with pregabalin, and their progress will be monitored over a year. This study is important because it aims to find better treatment options for individuals suffering from BMS who have not responded to standard medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients with a confirmed diagnosis of BMS based on the International Classification of Orofacial Pain, 1st edition \[International Classification of Orofacial Pain, 1st edition (ICOP) Cephalalgia, 2020\]
• • patients of any race or gender; complaining of oral burning recurring daily for \>2 h per day for \>3 months;
• • normal blood test findings (including blood count, blood glucose levels, glycated hemoglobin, serum iron, ferritin and transferrin).
• • BMS patients previously treated with one antidepressant for 12 weeks and non-responder to the treatment
• Exclusion Criteria:
• • the presence of any disease that could be recognized as a causative factor of BMS,
• • a history of a psychiatric disorder or a neurological or organic brain disorder,
• • a history of alcohol or substance abuse,
• • the presence of Obstructive Sleep Apnea Syndrome (OSAS)
• • uncontrolled hypertension, diabetes, HIV, narrow-angle glaucoma, or participants enrolled in other investigational studies.
• • participants requiring continued treatment with medications that adversely interact with the study medications (eg, quinolone antibiotics, warfarin, agents inhibiting serotonin reuptake) or with hereditary problems of fructose intolerance, glucose galactose malabsorption, or sucrose isomaltase insufficiency
• • pregnancy and lactation were exclusion criteria, and women of childbearing potential were required to receive a highly effective form of contraception.