RecruitingPhase 3NCT06986460

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

Sponsor

Tyler Kaster

Enrollment

80 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Bipolar Depression Depressed Phase

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether repetitive transcranial magnetic stimulation (rTMS) — a non-invasive procedure that uses magnetic pulses to stimulate specific parts of the brain — can reduce depression in people with bipolar disorder who did not respond to a prior treatment study. **You may be eligible if...** - You are 18 or older - You have a diagnosis of bipolar disorder (type I or II) and are currently in a depressive episode - You participated in the TRIBE trial and did not achieve sufficient improvement in depression after 6 weeks - You are currently an outpatient - You scored 10 or above on the PHQ-9 depression scale at your last assessment - It has been 3 months or less since you completed the TRIBE study **You may NOT be eligible if...** - You are currently experiencing a manic episode - You did not participate in the TRIBE trial - You have other conditions that would make rTMS unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagPro X100/R30 stimulator, Cool-B70 coil

1Hz rTMS delivered to the right DLPFC

Locations(2)

University Health Network Toronto Western Hospital

Toronto, Ontario, Canada

Centre For Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

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NCT06986460