The OLO trial evaluates the effectiveness of Saint technology for the treatment of major depressive disorder (MDD). The platform delivers individualized, rapid-acting, non-invasive neurostimulation. Saint treats adults who fail to achieve satisfactory improvement from prior antidepressant medications in the current episode.
FDA cleared Saint for treating MDD in September 2022.
Saint combines advanced imaging technologies and personalized targeting and novel stimulation patterns. It uses structural and functional MRI to inform a proprietary algorithm. The algorithm identifies the optimal anatomic target for focused neurostimulation in people with MDD.
“We are very pleased to announce the start of the OLO clinical trial with Saint therapy for people with MDD who are ineffectively treated by prior antidepressant medications,” said Dr. Brandon Bentzley, co-founder and chief scientific officer of Magnus. “Results from the previous randomized 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.
More about the Magnus Medical trial
OLO marks the first trial evaluating Saint across multiple sites. This offers a large sample size of adults to access the treatment. The trial includes up to nine clinics set to enroll up to 1,000 adults. These adults are suffering from an MDD episode. They failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Treatment comes on an accelerated timeline with 10 sessions per day. These feature 10-minute Saint treatments and 50-minute breaks over the course of five days. Magnus expects trial results in 2027.
Dr. David Carreon said Saint therapy enables fast, effective and personalized treatments that offer hope to patients for whom traditional approaches failed. Carreon serves as primary investigator and the first to enroll in the OLO study at Acacia Mental Health, Sunnyvale, California.
“It could profoundly change the way we care for those with treatment-resistant depression and be a model for addressing other conditions as well,” he said.
