Clinical Trial

Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression

Study acronym: FLARE

Recruiting Phase 3

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.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2025-05-15; most recent amendment 2026-03-16.

Status change: Not Yet Recruiting → Recruiting 2026-03-16

Trial Details

NCT Number	NCT06986460
Lead Sponsor	Tyler Kaster Collaborators: The Poul Hansen Family Centre for Depression, Toronto Western Hospital, Canada, University Health Network, Toronto
Conditions	Bipolar Depression Depressed Phase
Enrollment	80 participants
Start Date	2025-05-27
Primary Completion	2030-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-18