Unknown PHASE3 INTERVENTIONAL 6-arm NCT06025474

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

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

Sponsor: Federico II University

Conditions Burning Mouth Syndrome

Interventions Citalopram 20mg Duloxetine 60 MG Escitalopram 10mg Paroxetine 20 Mg Oral Tablet Pregabalin 75mg Sertraline 50 MG Vortioxetine 20Mg Tab

Updated 4 times since 2023 Last updated: Aug 29, 2023 Started: Jan 1, 2023 Primary completion: Oct 30, 2023 Completion: Jul 24, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Burning Mouth Syndrome, this trial is ongoing. The trial is conducted by Federico II University and has accumulated 4 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

4 versions recorded

Oct 2025 — Present [monthly]

Unknown PHASE3

Status: Recruiting → Unknown
Sep 2024 — Oct 2025 [monthly]

Recruiting PHASE3
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Oct 2023 — Jul 2024 [monthly]

Recruiting PHASE3

First recorded

Jan 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Federico II University

Data source: Federico II University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Napoli, Italy