Actively Recruiting
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Led by Tyler Kaster · Updated on 2026-03-18
80
Participants Needed
2
Research Sites
257 weeks
Total Duration
On this page
Sponsors
T
Tyler Kaster
Lead Sponsor
T
The Poul Hansen Family Centre for Depression
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able to provide informed consent
- Must be an outpatient
- Have a DSM 5 diagnosis of bipolar disorder (type I or II), current depressed episode confirmed by MINI
- Be older than 18 years
- Did not achieve sufficient clinical response (<=50% improvement) in prior TRIBE study
- Score 10 or higher on PHQ-9 at 6 weeks follow-up in TRIBE study and at screening
- Completed TRIBE study at least 3 months ago
- Not currently in mixed or manic episode (YMRS <=10)
- No increase or start of psychotropic medication for depression in 4 weeks before screening, except certain sleep treatments
- Currently treated with a non-anticonvulsant mood stabilizer with evidence for preventing mania
- Able to follow the treatment schedule
- Pass the TMS adult safety screening questionnaire
You will not qualify if you...
- History of substance use disorder (except nicotine/caffeine) in last 3 months
- Major unstable medical illness
- Active suicidal intent
- Pregnant or planning pregnancy during study
- Lifetime diagnosis of schizophrenia or schizoaffective disorder
- Psychotic symptoms in current episode
- Primary anxiety, trauma-related, OCD, or personality disorder causing more impairment than bipolar depression
- Failure of adequate electroconvulsive therapy (ECT) during current episode
- Significant neurological disorder or seizure history except certain cases
- Intracranial metal implants or objects that cannot be safely removed
- Unstable psychotherapy treatment within 3 months or expected changes during study
- Clinically significant abnormal lab results
- Taking lorazepam 2 mg or more daily or any anticonvulsant
- Insufficient time since stopping anticonvulsants before screening
- Significant sensory impairment preventing cooperation
- Withdrawal from prior TRIBE study for safety or PI discretion
- Recent substance use posing safety concern for rTMS as assessed by study investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Health Network Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
2
Centre For Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada, M6J 1H1
Actively Recruiting
Research Team
E
Elizabeth Clancy
CONTACT
M
Mawahib Semeralul
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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