Low Frequency rTMS for Bipolar Depression

(FLARE Trial)

Recruiting at 1 trial location

Overseen By Mawahib Semeralul

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tyler Kaster

Must be taking: Non-anticonvulsant mood stabilizers

Must not be taking: Anticonvulsants, High-dose lorazepam

Disqualifiers: Substance use, Schizophrenia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

Duration: 4 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tyler Kaster

Principal Investigator

CAMH

Eligibility Criteria

This trial is for individuals with treatment-resistant Bipolar Depression (BD-DE) who haven't improved after other therapies like iTBS or sham treatment. Participants should be able to attend daily sessions for 30 days and follow-ups.

Inclusion Criteria

I haven't started or increased depression meds in the last 4 weeks.

Must pass the TMS adult safety screening questionnaire

I understand the details of the clinical trial and can agree to participate.

Exclusion Criteria

I am not currently taking any anticonvulsant medication.

Must not have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months

I have not had unsuccessful ECT treatment for my current health issue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 days of low frequency rTMS treatment for bipolar depression

4 weeks

30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

2 visits (in-person)

Treatment Details

Interventions

• Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS

Trial Overview The study tests low frequency repetitive Transcranial Magnetic Stimulation (rTMS) on the right Dorsolateral Pre Frontal Cortex. It aims to see if this can help those with BD-DE when standard treatments fail, measuring depression and mania symptoms over time.

Participant Groups

Group I: Low frequency (1Hz) rTMS to the Right Dorsolateral Prefrontal Cortex Experimental Treatment 1 Intervention

Individuals will all receive 30 treatments of low frequency (1Hz) rTMS delivered to the Right Dorsolateral Prefrontal Cortex. rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling.

Who Is Running the Clinical Trial?

Tyler Kaster

Lead Sponsor

The Poul Hansen Family Centre for Depression

Collaborator

University Health Network (UHN)

Collaborator

Trials

1

Recruited

40+

Toronto Western Hospital, Canada

Collaborator