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

Recruiting Phase 3 Interventional Study
Bipolar Depression Depressed Phase
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Tyler Kaster · Other
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About 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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Must be deemed to have capacity to provide informed consent; 2. Must be an outpatient; 3. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI) assessed during TRIBE…
Contacts

Elizabeth Clancy

416-535-8501

Elizabeth.Clancy@camh.ca

CONTACT

Mawahib Semeralul

416-535-8501

mawahib.semeralul@camh.ca

CONTACT