Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 5, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06986460). This is a study registration, not published results. Lead sponsor: Tyler Kaster. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Bipolar Depression Depressed Phase. Interventions: DEVICE: MagPro X100/R30 stimulator, Cool-B70 coil. Primary outcome measures: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) , 6 weeks. 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.