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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine+Pregabalin | Experimental | 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 |
|
| Paroxetine+Pregabalin | Active Comparator | 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 |
|
| Sertraline+Pregabalin | Active Comparator | 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 |
|
| Citalopram+Pregabalin | Active Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 20Mg Tab | Drug | Encapsulated vortioxetine immediate release tablets, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) (Hayes and Patterson, 1921) is a well-validated unidimensional instrument for the measure of pain intensity (Hawker et al., 2011). The score is determined by measuring the distance on the line between the "no pain" and the mark of a patient mark, providing a range of scores from 0 to 10 (0 = no oral symptoms and 10 = the worst imaginable discomfort). | 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks |
| Short-form McGill Pain Questionnaire (SF-MPQ) | the short form of the McGill Pain Questionnaire (SF-MPQ) is a measure of the quality of pain and is a multidimensional pain questionnaire, which measures the sensory, affective, and evaluative aspects of the perceived pain (Hawker et al., 2011). It comprises 15 items from the original MPQ, each scored from 0 (none) to 3 (severe). The SF-MPQ score is obtained by summing the item scores (range 0-45). There are no established critical cutoff points for the interpretation of the scores and, as for the MPQ, a higher score indicates the worse pain. | 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton rating scale for Depression (HAM-D) | The HAM-D is a clinician-administered depression assessment scale; it contains 21 items pertaining to the affective field. The scores can range from 0 to 54. A score > 7 indicates an impairment. The scores in the range of 7-17 indicate a mild depression, the scores between 18 and 24 indicate a moderate depression, and the scores >24 indicate a severe depression |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale - Improvement (CGI-I) and Severity (CGI-S) | CGI-I scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Adamo | Contact | +39 3925253864 | danielaadamo.it@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Recruiting | Naples | Italia | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34497709 | Background | 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. | |
| 32790904 | Background | 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. |
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|
| Escitalopram+Pregabalin | Active Comparator | 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 |
|
| Duloxetine+Pregabalin | Active Comparator | 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 |
|
| Paroxetine 20 Mg Oral Tablet | Drug | Encapsulated paroxetine tablets, once daily |
|
| Sertraline 50 MG | Drug | Encapsulated sertraline tablets, once daily |
|
| Citalopram 20mg | Drug | Encapsulated citalopram tablets, once daily |
|
| Escitalopram 10mg | Drug | Encapsulated escitalopram tablets, once daily |
|
| Duloxetine 60 MG | Drug | Encapsulated duloxetine tablets, once daily |
|
| Pregabalin 75mg | Drug | Encapsulated pregabalin tablets, once daily |
|
| 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks |
| Hamilton rating scale for Anxiety (HAM-A) | The HAM-A (Hamilton, 1959) is a clinician-administered anxiety assessment scale. It comprises 14 items to measure both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0-4, a total score <17 indicates a mild severity, 18-24 mild to moderate, and 25-30 moderate to severe (Hamilton, 1967). | 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI (Buysse et al., 1989) explores the quality of sleep over a 1-month time interval generating seven "component" scores (0-3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction (Carpenter and Andrykowski, 1998). The total score is obtained by the sum of all the sub-scores and ranges between 0 and 21. A total score greater than five discriminates poor sleepers from good sleepers with a high sensitivity (90%-99%) and specificity (84%-87%) (Curcio et al., 2013). | 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks |
| 3 times evaluation: time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks |
| 40016875 | Derived | Adamo D, Canfora F, Pecoraro G, Leuci S, Coppola N, Marenzi G, Ottaviani G, Rupel K, Pellegrini L, Aria M, D'Aniello L, Mignogna MD, Albert U. Vortioxetine versus SSRI/SNRI with Pregabalin Augmentation in Treatment-Resistant Burning Mouth Syndrome: A Prospective Clinical Trial. Curr Neuropharmacol. 2025;23(7):800-819. doi: 10.2174/1570159X22999240729103717. |
| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D017374 | Paroxetine |
| D013607 | Tablets |
| D020280 | Sertraline |
| D015283 | Citalopram |
| D000089983 | Escitalopram |
| D000068736 | Duloxetine Hydrochloride |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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