Comparing vortioxetine and other antidepressants with pregabalin for burning mouth syndrome
Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome: a Prospective Longitudinal Clinical Trial With Treatment Response Prediction
This study is testing whether vortioxetine, along with pregabalin, can help people with Burning Mouth Syndrome who haven't found relief from other antidepressants.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 203 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Napoli, Italia) |
| Trial ID | NCT06025474 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of vortioxetine compared to other antidepressants, such as SSRIs and SNRIs, when augmented with pregabalin in patients suffering from Burning Mouth Syndrome (BMS) who have not responded to previous antidepressant treatment. The study will involve 203 participants who have experienced daily oral burning for over three months and have been treated with one antidepressant for at least 12 weeks without success. Participants will be randomly assigned to receive either vortioxetine or another antidepressant, and their treatment responses will be monitored over a 52-week period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with burning mouth syndrome who have not found relief from previous antidepressant treatments.
Not a fit: Patients with underlying conditions causing burning mouth syndrome or those with a history of psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with burning mouth syndrome who have not responded to standard antidepressant therapies.
How similar studies have performed: While there have been studies on antidepressants for chronic pain, this specific comparison with vortioxetine and pregabalin in BMS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Napoli, Italia
- University of Naples Federico II — Napoli, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Daniela Adamo
- Email: danielaadamo.it@gmail.com
- Phone: +39 3925253864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.