Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT04999553
Status:
RECRUITING
Last Update Posted:
2021-11-10
First Post:
2021-08-02
Brief Title:
Left vs Right Non-Inferiority Trial
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Left Intermittent Theta Burst Stimulation vs Right Low Frequency Repetitive Transcranial Magnetic Stimulation Effectiveness in Depression and Suicidal Ideation A Randomized Non-Inferiority Trial
Status:
RECRUITING
Status Verified Date:
2021-11
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:
LeRNIT
Brief Summary:
The aim of this study is to test the hypothesis that low-frequency rTMS LFR works as well as the established intermittent thetaburst rTMS iTBS treatment for treatment resistant depression TRD
Detailed Description:
In this multi-centre triple-blinded non-inferiority trial 420 patients with TRD will be recruited at two academic centres UBC CAMH Patients will be randomised to receive either iTBS or LFR for 30 sessions The primary outcome will be the improvement on a depression scale Secondary outcome will be improvement of suicidal ideation A secondary aim is to test the predictive capacity of a novel easy to implement heart rate based biomarkers ie heart rate variability
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