Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03257397
Status:
UNKNOWN
Last Update Posted:
2019-03-13
First Post:
2017-08-18
Brief Title:
TBS in Major Depression
Sponsor:
Rupert Lanzenberger
Organization:
Medical University of Vienna
Study Overview
Official Title:
Theta-burst Transcranial Magnetic Stimulation for the Treatment of Major Depression
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
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 Major depression is associated with morbidity and increased mortality Along with the psychological strain depression represents a high socioeconomic burden costing Europe more than 113 billionyear About one third of patients do not respond to appropriate therapy Theta-burst stimulation TBS a form of transcranial magnetic stimulation is an emerging treatment for patients for whom pharmacological treatment is ineffective or not appropriate Based on two different theories of prefrontal dysfunction two TBS-protocols should have the most antidepressant effects However no study so far has compared the two approaches or systematically investigated their differential effects on brain function and on a symptom level
Objectives of the study The aim of this study is to test two TBS protocols on symptom improvement and associated brain function in patients with treatment resistant depression TRD iTBS over bilateral DLPFC and iTBS over left and cTBS over right DLPFC As stimulation over non-motor regions offers no direct readout fMRI at baseline and after treatment will be harnessed to quantify an effect on brain activity and functional network metrics
Study population 80 patients with TRD will be enrolled with 40 patients receiving the one and 40 patients receiving the other TBS protocol for a treatment period of three weeks
Study design The study is designed as a longitudinal randomized and double-blind clinical trial At baseline and after treatment patients will undergo psychiatric testing using several symptom scales including the Hamilton Depression Rating Scale HAMD-17 the Beck Depression Inventory BDI-II the Inventory of Depressive Symptomatology IDS-C and the State-Trait Anxiety Inventory STAI Changes in HAMD-17 scores are defined as primary endpoint Moreover MRI scans before and after treatment will include structural and functional MRI sequences as well as diffusion weighted imaging DWI sequence Functional connectivity and BOLD responses will serve as primary imaging endpoints A follow-up visit 2 weeks and a final examination 4 weeks after treatment will elucidate durability of effects
Relevance and implications of the study By investigating which approach is superior for which symptoms our study will contribute to the development of personalized treatment the reduction of personal suffering and the reduction of costs and occupational disability
Objectives of the study The aim of this study is to test two TBS protocols on symptom improvement and associated brain function in patients with treatment resistant depression TRD iTBS over bilateral DLPFC and iTBS over left and cTBS over right DLPFC As stimulation over non-motor regions offers no direct readout fMRI at baseline and after treatment will be harnessed to quantify an effect on brain activity and functional network metrics
Study population 80 patients with TRD will be enrolled with 40 patients receiving the one and 40 patients receiving the other TBS protocol for a treatment period of three weeks
Study design The study is designed as a longitudinal randomized and double-blind clinical trial At baseline and after treatment patients will undergo psychiatric testing using several symptom scales including the Hamilton Depression Rating Scale HAMD-17 the Beck Depression Inventory BDI-II the Inventory of Depressive Symptomatology IDS-C and the State-Trait Anxiety Inventory STAI Changes in HAMD-17 scores are defined as primary endpoint Moreover MRI scans before and after treatment will include structural and functional MRI sequences as well as diffusion weighted imaging DWI sequence Functional connectivity and BOLD responses will serve as primary imaging endpoints A follow-up visit 2 weeks and a final examination 4 weeks after treatment will elucidate durability of effects
Relevance and implications of the study By investigating which approach is superior for which symptoms our study will contribute to the development of personalized treatment the reduction of personal suffering and the reduction of costs and occupational disability
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?:
None
Is an FDA AA801 Violation?:
None