NCT06025474

Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in 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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 symptoms in most cases; however, a subset of patients exhibit limited or no response to these treatments. The augmentation with pregabalin to conventional treatment has shown promising outcomes in relieving pain and improving quality of life in chronic pain conditions. This study aimed to compare the efficacy of vortioxetine with other antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS patients and to predict treatment response using clinical data. Methods: A 52-week randomized, open-label, active-controlled study was conducted, enrolling 203 BMS patients previously treated with one antidepressant for 12 weeks and non-responder to the treatment. The study sample have included two groups: Group A (136) received vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75mg/day) was added to both groups, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks. Treatment response was assessed by measuring reduction in VAS and SF-MPQ scores (\>50 or 1-2) and HAM-A and HAM-D scores (\>50% or ≤7) at 12, 24, 36 and 52 weeks. Classical logistic regression with a stepwise algorithm and Random Forest machine learning models were used to predict treatment response.

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
DRUG	Vortioxetine 20Mg Tab	Encapsulated vortioxetine immediate release tablets, once daily
DRUG	Paroxetine 20 Mg Oral Tablet	Encapsulated paroxetine tablets, once daily
DRUG	Sertraline 50 MG	Encapsulated sertraline tablets, once daily
DRUG	Citalopram 20mg	Encapsulated citalopram tablets, once daily
DRUG	Escitalopram 10mg	Encapsulated escitalopram tablets, once daily
DRUG	Duloxetine 60 MG	Encapsulated duloxetine tablets, once daily
DRUG	Pregabalin 75mg	Encapsulated pregabalin tablets, once daily

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-10-30
• Completion: 2024-07-24
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: Italy