Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04581902
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-07-27
Brief Title:
Biomarkers of Depression and Treatment Response
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Biomarkers of Depression and Treatment Response
Status:
RECRUITING
Status Verified Date:
2023-11
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:
SUNSET
Brief Summary:
This study is a stratified parallel-group single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder MDD The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation TMS treatment
Detailed Description:
First the study will examine the replicability and prognostic utility of two previously identified potential biomarkers for MDD using resting state imaging Second investigators will conduct an exploratory whole brain analysis combining EEG and imaging techniques to identify new potential biomarkers for MDD and treatment response as participants complete a course of TMS treatment It is the hope to shed new light on the mechanisms underlying depression and relapse which may allow for a more effective personalized selection of treatment course
Participants will complete initial screening and baseline evaluation along with resting-state functional magnetic resonance imaging fMRI diffusion tensor imaging DTI and electroencephalography EEG scans prior to the initial TMS treatment Participants will complete 30-36 TMS sessions and a post-treatment evaluation along with mid- and post-treatment fMRI DTI and EEG scans
It is anticipated that participants with MDD have a specific set of neural features that can classify with high precision patients with MDD from those who do not and that align with clinical diagnoses This set of neural features will change across the course of treatment Further investigators expect that improvement as rated by a common MDD measure is modulated by time of treatment
Participants will complete initial screening and baseline evaluation along with resting-state functional magnetic resonance imaging fMRI diffusion tensor imaging DTI and electroencephalography EEG scans prior to the initial TMS treatment Participants will complete 30-36 TMS sessions and a post-treatment evaluation along with mid- and post-treatment fMRI DTI and EEG scans
It is anticipated that participants with MDD have a specific set of neural features that can classify with high precision patients with MDD from those who do not and that align with clinical diagnoses This set of neural features will change across the course of treatment Further investigators expect that improvement as rated by a common MDD measure is modulated by time of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None