Magnus Medical has announced the treatment of the first participants in the Open-Label Optimisation (OLO) clinical trial of the SAINT neuromodulation system for major depression.
The study is intended to assess the effectiveness of the Magnus Neuromodulation System with SAINT Technology to treat major depressive disorder (MDD).
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Leveraging structural and functional magnetic resonance imaging, the Magnus Neuromodulation System with SAINT Technology will inform an algorithm for identifying the optimal anatomic brain target for focused neurostimulation in individuals with MDD.
The trial will involve the participation of up to nine clinics across the US and enrol up to 1,000 adults with a major depressive episode who could not receive satisfactory improvement from previous antidepressant medication in the current episode.
The participants will receive the treatment on an accelerated schedule, with ten sessions a day, comprising ten-minute SAINT therapy treatments with breaks of 50 minutes for five consecutive days.
Magnus expects the results from the trial in 2027.
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By GlobalDataMagnus co-founder and chief scientific officer Dr Brandon Bentzley said: “Results from the previous randomised controlled trial were extremely promising – 79% of participants experienced relief from their severe depression after receiving SAINT treatment.
“Given the enormous need for acute care in depression, we knew we needed to make SAINT treatment more widely available while building a body of clinical data.”
The company secured breakthrough device designation from the US Food and Drug Administration for the Magnus Neuromodulation System with SAINT Technology for treatment-resistant depression.
