Vortioxetine versus other antidepressants in the treatment of Burning Mouth Syndrome

Which is the best? Vortioxetine versus other antidepressants in the treatment of Burning Mouth Syndrome: an open-label randomized active-controlled 12-month trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13795228

Enrollment

150

Registered

2020-05-25

Start date

2019-02-01

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome Digestive System Glossodynia, Burning Mouth Syndrome

Interventions

Age and sex-matched participants will be randomly assigned to 5 study groups in a ratio of 1:1:1:1:1. 1. Vortioxetine (VO) group where patients treated with Vortioxetine (15mg /daily)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Continuous symptoms of oral burning or pain persisting for at least two hours per day, lasting for longer than three months, with no paroxysms and not following any unilateral nerve trajectory 3. No clinical mucosal alterations 4. Normal blood test findings (including blood count, blood glucose, serum iron, ferritin and transferrin, folic acid and vitamin B12 levels) 5. Body Mass Index (BMI) of <30 6. No previous treatment with systemic psychotropic drugs

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding 2. Suffering from diseases that could be recognized as a causative factor of BMS 3. Unable to understand the questionnaires 4. History of a psychiatric disorder or suffering from a degenerative and progressive neurological disease 5. Undergoing treatment with a psychotropic drug 6. Previously treated with an antidepressant 7. History of alcohol or substance abuse

Design outcomes

Primary

Measure	Time frame
1. Efficacy of Vortioxetine and other antidepressants, measured using: 1.1. Intra- and extra-oral examination baseline and after 2, 3, 6, and 12 months 1.2. The Visual Analogue Scale (VAS) at baseline and after 2, 4, 6, and 12 months 1.3. The Total Pain Rating Index (T-PRI) at baseline and after 2, 4, 6, and 12 months 1.4. The Hamilton Rating Scale for Anxiety (HAM-A) at baseline and after 2, 4, 6, and 12 months 1.5. The Hamilton Rating Scale for Depression (HAM-D) at baseline and after 2, 4, 6, and 12 months 1.6. The Clinical Global Impression Improvement scale (CGI-I) at 6 and 12 months 1.7. The Clinical Global Impression Efficacy Index (CGI-E) at 6 and 12 months Calculated as the percentage of patients who showed a remission or a response, at 6 months and 12 months. Clinical remission to treatment was defined as: the absence of any oral symptoms, or occasional and very limited oral symptoms, at the time with VAS score between 0 and 2 and T-PRI score between 0 and 5; HAM-A and HAM-D scores = 7; and CGI-I and CGI-E scores of 1. Clinical response to treatment was defined as: an improvement in the oral symptoms, which were still present with a reduction of the scores of VAS and T-PRI of > 50%; a reduction of the scores of the HAM-A and HAM-D by > 50%, or HAM-A and HAM-D scores = 7; and CGI-I score between 1 and 2 and CGI-E scores between 1 and 2 or between 5 and 6. 2. Occurrence of specific adverse events for Vortioxetine and other antidepressants measured as a percentage of patients who reported AEs over the trial period, at 2, 4, 6, and 12 months	—

Measure

Time frame

1. Efficacy of Vortioxetine and other antidepressants, measured using: 1.1. Intra- and extra-oral examination baseline and after 2, 3, 6, and 12 months 1.2. The Visual Analogue Scale (VAS) at baseline and after 2, 4, 6, and 12 months 1.3. The Total Pain Rating Index (T-PRI) at baseline and after 2, 4, 6, and 12 months 1.4. The Hamilton Rating Scale for Anxiety (HAM-A) at baseline and after 2, 4, 6, and 12 months 1.5. The Hamilton Rating Scale for Depression (HAM-D) at baseline and after 2, 4, 6, and 12 months 1.6. The Clinical Global Impression Improvement scale (CGI-I) at 6 and 12 months 1.7. The Clinical Global Impression Efficacy Index (CGI-E) at 6 and 12 months Calculated as the percentage of patients who showed a remission or a response, at 6 months and 12 months. Clinical remission to treatment was defined as: the absence of any oral symptoms, or occasional and very limited oral symptoms, at the time with VAS score between 0 and 2 and T-PRI score between 0 and 5; HAM-A and HAM-D scores = 7; and CGI-I and CGI-E scores of 1. Clinical response to treatment was defined as: an improvement in the oral symptoms, which were still present with a reduction of the scores of VAS and T-PRI of > 50%; a reduction of the scores of the HAM-A and HAM-D by > 50%, or HAM-A and HAM-D scores = 7; and CGI-I score between 1 and 2 and CGI-E scores between 1 and 2 or between 5 and 6. 2. Occurrence of specific adverse events for Vortioxetine and other antidepressants measured as a percentage of patients who reported AEs over the trial period, at 2, 4, 6, and 12 months

—

Secondary

Measure	Time frame
1. Drop out measured as the percentage of patients who left the trial early due to any reason up to the end of the study duration, recorded at the time of drop out by 12 months 2. Drop out due to adverse events (tolerability) measured as the percentage of patients who left the trial early due to adverse events, recorded at the time of drop out by 12 months	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026