Status:
UNKNOWN
Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome
Lead Sponsor:
Federico II University
Conditions:
Burning Mouth Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 sy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 24 2024
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT06025474
Start Date
January 1 2023
End Date
July 24 2024
Last Update
September 6 2023
Active Locations (1)
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1
University of Naples Federico II
Napoli, Italia, Italy, 80131