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

NCT06986460 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Bipolar Depression Depressed Phase

Interventions

DEVICE

MagPro X100/R30 stimulator, Cool-B70 coil

1Hz rTMS delivered to the right DLPFC

Sponsors & Collaborators

  • The Poul Hansen Family Centre for Depression

    collaborator UNKNOWN

  • Toronto Western Hospital, Canada

    collaborator UNKNOWN

  • University Health Network (UHN)

    collaborator UNKNOWN

  • Tyler Kaster

    lead OTHER

Principal Investigators

  • Tyler Kaster · CAMH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2030-05-31
Completion
2030-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06986460 on ClinicalTrials.gov