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

Last updated: August 29, 2023
Sponsor: Federico II University
Overall Status: Active - Recruiting

Phase

3

Condition

Oral Facial Pain

Hyponatremia

Skin Wounds

Treatment

Sertraline 50 MG

Citalopram 20mg

Pregabalin 75mg

Clinical Study ID

NCT06025474
251/19
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

  • patients with a confirmed diagnosis of BMS based on the International Classificationof Orofacial Pain, 1st edition [International Classification of Orofacial Pain, 1stedition (ICOP) Cephalalgia, 2020]
  • patients of any race or gender; complaining of oral burning recurring daily for >2 hper day for >3 months;
  • normal blood test findings (including blood count, blood glucose levels, glycatedhemoglobin, serum iron, ferritin and transferrin).
  • BMS patients previously treated with one antidepressant for 12 weeks and non-responderto the treatment

Exclusion

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 participantsenrolled in other investigational studies.
  • participants requiring continued treatment with medications that adversely interactwith the study medications (eg, quinolone antibiotics, warfarin, agents inhibitingserotonin reuptake) or with hereditary problems of fructose intolerance, glucosegalactose malabsorption, or sucrose isomaltase insufficiency
  • pregnancy and lactation were exclusion criteria, and women of childbearing potentialwere required to receive a highly effective form of contraception.

Study Design

Total Participants: 203
Treatment Group(s): 7
Primary Treatment: Sertraline 50 MG
Phase: 3
Study Start date:
January 01, 2023
Estimated Completion Date:
July 24, 2024

Connect with a study center

  • University of Naples Federico II

    Napoli, Italia 80131
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.