Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT06986460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Sponsor:
Tyler Kaster
Organization:
Study Overview
Official Title:
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
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:
FLARE
Brief Summary:
The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering. Participants will come for 30 days of LFR, 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:
False
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?: