Clinical trial NCT06025474: Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Burning Mouth Syndrome
Keywords: Burning mouth syndrome
vortioxetine
pregabalin
Drug Therapy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
measure: Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
Secondary outcomes:
measure: Hamilton rating scale for Depression (HAM-D)
timeFrame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
measure: Hamilton rating scale for Anxiety (HAM-A)
timeFrame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
Other outcomes:
measure: Clinical Global Impression Scale - Improvement (CGI-I) and Severity (CGI-S)
timeFrame: 3 times evaluation: time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
Locations:
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Italia
Study officials:
References:
citation: Adamo D, Calabria E, Coppola N, Pecoraro G, Mignogna MD. Vortioxetine as a new frontier in the treatment of chronic neuropathic pain: a review and update. Ther Adv Psychopharmacol. 2021 Sep 3;11:20451253211034320. doi: 10.1177/20451253211034320. eCollection 2021.
citation: Adamo D, Pecoraro G, Coppola N, Calabria E, Aria M, Mignogna M. Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial. Oral Dis. 2021 May;27(4):1022-1041. doi: 10.1111/odi.13602. Epub 2020 Sep 15.