Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025474
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-29
Brief Title:
Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SSRIsSNRIs 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 SSRIsSNRIs Pregabalin 75mgday was added to both groups with a potential dosage increase to 150mgday 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
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 SSRIsSNRIs Pregabalin 75mgday was added to both groups with a potential dosage increase to 150mgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None