NCT06370988

Theta-Burst Stimulation for Bipolar Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.

Conditions

• Bipolar Depression
• Bipolar Disorder
• Treatment- Resistant Bipolar Disorder
• Type 2 Bipolar Disorder

Interventions

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

Timeline

• Start date: 2024-05-15
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2024-04-17
• Last updated: 2026-03-18

Locations

2 sites across 1 country: Canada