Monthly Archives: October 2021

FDA’s Breakthrough Device Designation for rapid-acting technology to treat major depression

Non-invasive neurostimulation technology to rapidly treat major depressive disorder (MDD) 

The FDA has awarded Breakthrough Device Designation to Magnus Medical’s non-invasive technology to rapidly treat major depressive disorder (MDD) in adults who have not responded to existing treatments. The Magnus System is based on the SAINT technology (Stanford Accelerated Intelligent Neuromodulation Therapy), a form of transcranial magnetic stimulation which was licensed exclusively to Magnus Medical from Stanford University for commercialization.

An advance online article published in the American Journal of Psychiatry, describe the results from an investigational double-blinded randomized controlled trial (RCT) evaluating SAINT suggest that the novel approach has the potential to be a reproducible, rapid, and highly effective treatment for severe, refractory depression in a broader clinical setting. Fourteen study participants received active treatment, and another 15 received sham (placebo) treatment. The clinical trial results show that 79% of people in the active treatment arm entered remission—that is, experienced near elimination of their depression symptoms based on the Montgomery-Åsberg Depression Rating Scale (MADRS)—compared to people in the sham treatment arm, where only 13% entered remission. In an earlier pilot trial evaluating SAINT, 19 of 21 study participants (90%) entered remission. The restoration of healthy neural activity for the responders was life-changing as indicated by improvement in quality of life measures, and within five days, symptoms (including thoughts of suicide) improved dramatically. Data collected during both studies were evaluated by the FDA as part of the criteria for granting Breakthrough Device designation. 

The SAINT technology is described as having breakthrough algorithms that can identify optimal, personalized targets to affect brain circuitry based on structural and functional neuroimaging. Therefore, utilizing precise patterns of stimulation that can leverage recent advances in neuroscience and restore these neural circuits.

According to Magnus Medical, this system is a novel innovation with the potential to have a significant positive impact on the treatment of severe depression. For the first time, advanced imaging technologies combined with personalized neural targeting and novel stimulation patterns have the potential to yield a new form of individualized, non-invasive neurostimulation for people with treatment-resistant depression. This new approach is designed to be delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity.

The Magnus System, currently an investigational device, is expected to require 501(k) clearance from the U.S. FDA and is not yet commercially available.

Sources:

Cole EJ, Phillips AL, Bentzley BS, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. AJP Published Online:29 Oct 2021

Magnus Medical Press Release

Stanford University News

Columbia University Psychiatry Develops a Mobile Depression App

A major gap in diagnosing and managing major depression is that the frontline in the recognition of depression is staffed by primary care clinicians. Since depression is one of the leading causes of disability worldwide, busy PCPs can benefit from the latest tools and information to assist them in the assessment and treatment of patients who present with symptoms.

The app known as Columbia Psychiatry Pathways — supports and strengthens the ability of clinicians to provide critical mental health services in an outpatient setting. It was co-developed by Columbia Psychiatry faculty John Mann, MD and Ravi N. Shah, MD. in collaboration with avoMD, a next-gen clinical decision support platform, as an interactive smartphone application that provides point-of-care treatment algorithms for major depression. 

This clinical decision support tool, is available as a mobile and desktop app. It has been developed for use by psychiatrists, primary care physicians, nurse practitioners, physician assistants, medical students, residents, and trainees in outpatient settings as they treat patients with major depression. The evidence-based platform updates prior depression treatment guidelines and uses algorithms that focus on faster medication adjustments with emphasis on the best-tolerated generic antidepressants. It measures symptom severity using built-in calculators based on the Columbia Depression Scale and includes screenings for bipolar disorder and suicide risk. 

The division of primary care at Columbia welcomes the Psychiatry Pathways app and highlight that ‘it is challenging to treat major depression, especially in a primary care setting, especially in a patient with comorbid conditions. A point of care app that can serve as virtual consult can help to validate a PCP’s knowledge in the best possibl care for patients.’

Sources:

Columbia Psychiatry

avoMD