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.
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