Syntropic initiates first patient stimulation in home-based depression clinical trial
On September 5, 2025, the company reached a key clinical milestone with the First Patient First Visit (FPFV) in its light-based therapy trial. The study is testing a three-week course of home treatment followed by a two-week observation period. This represents Syntropic’s first formal move toward a decentralized care model for depression.
Major depressive disorder (MDD) remains one of the leading causes of disability worldwide. In 2019, more than 20 million adults in the U.S. were affected. Traditional treatments such as antidepressants often leave patients with incomplete remission and difficult side effects. Around 70% of individuals fail to respond adequately, highlighting the urgent demand for new solutions.
Syntropic Medical is addressing this need with its non-invasive, 60 Hz intermittent light stimulation (ILS)-based therapy. Previous studies in both healthy individuals and patients with depression have demonstrated the safety and potential of ILS to enhance neuroplasticity, a critical mechanism for recovery in depression.
The Clinical Trial
The upcoming clinical trial is designed to evaluate the feasibility, safety and tolerability of intermittent light stimulation in adults with moderate to severe depression. It involves 40 participants, each diagnosed with a major depressive episode (DSM-5) and maintaining a stable antidepressant regimen for at least six weeks. Over the course of three weeks, each participant undergoes 15 stimulation sessions at home. These sessions are followed by clinical follow-up visits, and efficacy is measured through changes in HDRS-17 scores and other validated scales assessing depression and anxiety symptoms.
The clinical trial is fully home‑based, conducted in collaboration with the Neuromodulation Lab in the Department of Neurology at NYU Langone Health, ranked #1 in the U.S. for neurology and neurosurgery by U.S. News & World Report.
The Neuromodulation Lab is led by Prof. Leigh Elkins Charvet, PhD, Professor of Neurology and Director of the transcranial Direct Current Stimulation (tDCS) Program at NYU Grossman School of Medicine.
The principal investigator of the NEON clinical trial is Dr. Giuseppina Pilloni, PhD, Research Assistant Professor in the Department of Neurology at NYU Grossman School of Medicine and co-leader of the Neuromodulation Lab at NYU Langone.
Contact
Mark Caffrey
CEO of Syntropic Medical