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

Federico II University

Status and phase: Enrolling; Phase 3

Conditions: Burning Mouth Syndrome

Treatments: Drug: Duloxetine 60 MG; Drug: Paroxetine 20 Mg Oral Tablet; Drug: Citalopram 20mg; Drug: Vortioxetine 20Mg Tab; Drug: Escitalopram 10mg; Drug: Sertraline 50 MG; Drug: Pregabalin 75mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06025474

251/19

Details and patient eligibility

About

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.

Enrollment: 203 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 6 patient groups

Vortioxetine+Pregabalin

Experimental group

Description:

VO group(20mg)+ PGB (75mg) N= 136 Vortioxetine 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks

Treatment:

Drug: Vortioxetine 20Mg Tab

Drug: Pregabalin 75mg

Paroxetine+Pregabalin

Active Comparator group

Description:

P group (20mg) + PGB (75mg); N= 10 Paroxetine 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks

Treatment:

Drug: Paroxetine 20 Mg Oral Tablet

Drug: Pregabalin 75mg

Sertraline+Pregabalin

Active Comparator group

Description:

S group (50mg) + PGB (75mg); N= 8 Sertraline 50 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks

Treatment:

Drug: Pregabalin 75mg

Drug: Sertraline 50 MG

Citalopram+Pregabalin

Active Comparator group

Description:

C group (20mg)+ PGB (75mg) N= 8 Citalopram 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks

Treatment:

Drug: Citalopram 20mg

Drug: Pregabalin 75mg

Escitalopram+Pregabalin

Active Comparator group

Description:

E group (10mg) + PGB (75mg); N= 8 Escitalopram 10 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks

Treatment:

Drug: Escitalopram 10mg

Drug: Pregabalin 75mg

Duloxetine+Pregabalin

Active Comparator group

Description:

D group (60mg)+ PGB (75mg) N= 33 Duloxetine 60 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks

Treatment:

Drug: Duloxetine 60 MG

Drug: Pregabalin 75mg