NCT04999553

Left vs. Right Non-Inferiority Trial

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 (i.e. heart rate variability).

Conditions

• Depression
• Major Depressive Disorder
• Major Depressive Episode

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation	rTMS will employ the MagPro X100/R30 stimulator equipped with the cool-B70 as we used a cool-B70 in our past non-inferiority trial. The dose will be a 120% rMT in accordance to our latest trial using iTBS. The target area to stimulate will be the right dorsolateral prefrontal cortex (DLPFC) for LFR and the left DLPFC for iTBS as established in prior clinical trials. The localization of both targets will follow the well-established procedures for either R-DLPFC or L-DLPFC using a heuristic method.
DEVICE	Intermittent Theta Burst Stimulation (iTBS)	Intermittent Theta Burst Stimulation (iTBS)
DEVICE	Low Frequency Right (LFR)	Low Frequency Right (LFR)

Timeline

• Start date: 2021-11-08
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2021-08-11
• Last updated: 2021-11-10

Locations

2 sites across 1 country: Canada