Trial intelligence / Profile preview

Vortioxetine vs Other Antidepressants with Pregabalin in Burning Mouth Syndrome

NCT06025474Phase 3

Key facts

Status: Unknown
Start: Jan 2023
Primary completion: Oct 2023
Countries: 1
Sponsor: University of Naples Federico II
Modality: Small Molecules

Drugs: vortioxetine
Conditions: burning mouth syndrome (BMS)

Overview

Phase 3, randomised, open-label trial of vortioxetine in burning mouth syndrome (BMS) (6 arms), sponsored by University of Naples Federico II. Primary endpoints: Visual Analog Scale at 52 weeks and Short-form McGill Pain Questionnaire at 52 weeks. Status: unknown.

Design

6 arms

Study design: RandomizedOpen-label

Vortioxetine+Pregabalin
Vortioxetine 20mg + Pregabalin 75-150mg
Paroxetine+Pregabalin
Paroxetine 20mg + Pregabalin 75-150mg
Sertraline+Pregabalin
Sertraline 50mg + Pregabalin 75-150mg
Citalopram+Pregabalin
Citalopram 20mg + Pregabalin 75-150mg
Escitalopram+Pregabalin
Escitalopram 10mg + Pregabalin 75-150mg
Duloxetine+Pregabalin
Duloxetine 60mg + Pregabalin 75-150mg

Endpoints

Primary

Visual Analog Scale52 weeks
Short-form McGill Pain Questionnaire52 weeks

Secondary

Hamilton Rating Scale for Depression52 weeks
Hamilton Rating Scale for Anxiety52 weeks
Pittsburgh Sleep Quality Index52 weeks

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