Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370988
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-15
Brief Title:
Theta-Burst Stimulation for Bipolar Depression
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Theta-Burst Stimulation for Bipolar Depression
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TRIBE
Brief 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
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