Fermata, an outpatient psychiatric center of excellence, today announced a new clinical trial to study the SAINT™ Neuromodulation System for treating major depressive disorder (MDD) as part of a larger multi-site trial to further develop a more rapid, personalized treatment option for treatment-resistant major depression.
The prospective, multi-site open-label optimization study (OLO) is designed to further evaluate the effectiveness of the investigational SAINT Neuromodulation System for the treatment of adults with MDD. The SAINT Neuromodulation System may yield a new form of personalized, focused neurostimulation in adults with major depression.
The OLO trial will enroll up to 1,000 adults in a major depressive episode who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode. According to the World Health Organization, over 280 million people suffer from MDD globally, nearly half of whom have treatment-resistant depression, and far too many experience suicidal thoughts with no rapidly acting treatment options available to them.1
“Major Depressive Disorder (MDD) is one of the most common mental disorders in the United States. Treatment-resistant depression (TRD) can leave sufferers feeling like they are out of options,” said Owen Scott Muir, M.D., a co-founder at Fermata and an ABPN dual-board certified Child and Adult Psychiatrist. “There is an enormous need for improved treatments for MDD. This trial will go a long way toward gathering more data to help us treat people with severe, even intractable, depression.” In his influential newsletter and podcast, TheFrontierPsychiatrists.com, Dr. Muir writes about health, including accessible payment models, and neuromodulation.
This study is the first time the SAINT Neuromodulation System has been studied at multiple sites in a large sample of individuals with major depression.
“We are entering a remarkable new era in mental health care,” said Carlene MacMillan, M.D., co-founder of Fermata and chief medical officer of Osmind, an electronic health record company for mental health providers. “This targeted, rapid neuromodulation protocol has the potential to reach patients across different levels of care.”
The SAINT Neuromodulation System uses MRI images of brain activity to identify the most strongly connected portions of the left dorsolateral prefrontal cortex with regard to a deeper subregion called the subgenual cingulate. In people who have MDD, the subgenual cingulate becomes overactive, and the ability to prevent negative thoughts is reduced. This study is investigating if SAINT will reduce the activity in the subgenual cingulate and restore mood regulation.2
Study treatment with the SAINT Neuromodulation System is delivered on an accelerated timeline—10 sessions a day, composed of 10-minute treatments with 50-minute breaks for five consecutive days.