Recruiting For A Depression Clinical Trial @ Fermata.health in Brooklyn, NY
Comparing two medication free treatments for depression.
Dear Readers, This missive will not be exciting to read because it announces a clinical trial and clinical trial announcements are carefully regulated. Without further ado…
Fermata.health is excited to announce a new DeepTMS clinical trial for Major Depression Disorder (ClinicalTrials.gov: NCT06357832).
This non-inferiority trial compares conventional (once daily) H1 Deep TMS to an investigational protocol with multiple daily H1 iTBS sessions for treatment-resistant depression. Participation is free.
Both groups receive active TMS at no cost.
The investigational group receives the new stimulation protocol, while the control group receives the FDA-cleared standard-of-care deep TMS protocol. Both groups will use the BrainsWay Deep TMS Device.
There will be no sham or placebo treatments.
Study participants must:
Be between 22 and 68 years old.
Have a primary DSM-5 diagnosis of Major Depression.
Have 1-4 antidepressant trials in the current episode.
Participants must not:
Have any previous/current psychotic or bipolar disorder.
Have an active alcohol or substance use disorder.
Have a current diagnosis of PTSD.
Have ferromagnetic metals in the head or neck.
Be pregnant or breastfeeding/chestfeeding.
Have a personal or family history of seizures, excluding febrile or ECT-induced seizures.
The trial is at our Brooklyn location, offering comfortable resting rooms with a couch and Wi-Fi for 50-minute intervals. We invite you to refer yourself or your patients for this trial.
And the email is info@fermata.health for inquiries!
Is this treatment contraindicated for epilepsy or is there some other reason for that exclusion?
Any limits on sample size or are you enrolling as many as you can? How long are you enrolling?