NCT04255784

High Dose Accelerated iTBS for Depression

A Randomized Sham-Controlled Trial of High-Dosage Accelerated Intermittent Theta Burst rTMS in Major Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.

Detailed description

Those participants who do not meet the response criterion (50% improvement from baseline on the HRDS-17) at the 4-week follow-up will be offered a second course of treatment, regardless of whether they were in the active or the sham treatment group. The blind will be maintained and no further assessment contributing to the primary or secondary outcomes will occur after the 4-week time point. A different operator will administer the open-label second course of treatment to ensure blinding of operators. The second course of treatment will apply active rTMS using low-frequency (1 Hz) stimulation to the right DLPFC for 600 pulses (10 minutes), 8x daily at 50 minutes (between session and end and start) intervals for 5 days. All those completing the second course of treatment will undergo the same set of clinical assessments during and after the course of treatment on the same schedule as the first course of treatment. The final 4-week follow up assessment from the first course of treatment will serve as the baseline for those that go on to receive the second open label treatment course.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Active iTBS	Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
DEVICE	Sham iTBS	Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30

Timeline

• Start date: 2020-02-06
• Primary completion: 2025-01-24
• Completion: 2025-01-24
• First posted: 2020-02-05
• Last updated: 2025-01-29

Locations

2 sites across 1 country: Canada