From Academia to Industry: Developing Software to Treat Depression

We need new and better ways to treat depression besides antidepressant medications, which many with depression would prefer not to take, and psychotherapies that can be costly and difficult to access.
From Academia to Industry: Developing Software to Treat Depression

The paper in npj Digital Medicine is here:

Major depressive disorder (MDD) is a potentially debilitating condition, and although treatments exist for MDD, there are many barriers to treatment for a significant portion of MDD sufferers. As such, novel treatments that are accessible to more MDD sufferers are sorely needed.  This is what motivated the development and evaluation of a novel treatment paradigm for MDD involving cognitive-emotional enhancement: the Emotional Faces Memory Task (EFMT). This publication in npj Digital Medicine reports on the second successful clinical trial of the efficacy of EFMT as an intervention for MDD.    

Over a decade of neuroscience and brain imaging research has taught us that those with MDD show imbalances in the activation patterns of regions in the brain that process emotion and exert cognitive control. The region of the brain that facilitates emotion processing tends to be hyper-active, while a region facilitating cognitive control and emotional regulation tends to be hypoactive. This leads to overwhelming emotional responses and can make emotion regulation difficult for MDD sufferers.

To put it simply, we need new and better ways to treat depression besides antidepressant medications which many MDD sufferers would prefer not to take, and psychotherapies that can be costly and difficult to access. This research is novel because it represents another treatment option besides medication or psychotherapy, but with a similar targeted effect: enhancing cognitive control over emotionally salient information. People with MDD get stuck on negative thoughts and emotional content, and we want to strengthen their cognitive control to remedy that.

To accomplish this, EFMT provides a consistent challenge wherein patients are asked to identify the emotions displayed on a series of faces and to exert cognitive control to respond to a memory challenge involving these emotional faces. The aim is to target one major thinking abnormality we see in patients with MDD -- that of perseverating, ruminating, obsessing, dwelling on the negative -- by re-training these two nodes (emotion processing and cognitive control) to activate simultaneously. The hypothesis was that by harnessing brain plasticity, these nodes can re-learn more balanced activation patterns as a result of this consistent challenge, giving the individual the capacity to exert more cognitive control over the emotional information they process and shift their attention so that they are not perseverating. With enhanced cognitive control, our program should in theory be able to significantly reduce the persistent symptoms of MDD. And when put into practice in 2 trials, that’s just what it did.

In the trials used to determine efficacy, a regimen of EFMT sessions was completed by the experimental group, while the control group completed a regimen of a similar task involving only working memory (and no emotion processing). At the end of the studies, those who received EFMT treatment showed an approximately 45% reduction in MDD symptoms versus only approximately 25% in the control group. That reduction in MDD symptoms is comparable to the response of prescription antidepressant treatments; but as a digital therapeutic, EFMT has a highly favorable safety profile in comparison to antidepressant medications and could overcome some of the access barriers to effective treatments.

I began investigating the technique and developing the technology behind EFMT in late 2009 with Dr. Dennis S. Charney, MD, and our team at Mount Sinai. Considering the encouraging research data supporting the efficacy of EFMT as a treatment for MDD, and a pilot brain imaging study that appeared to support the neuroplastic mechanism of action underlying EFMT, we made the decision to bring EFMT out of the academic laboratory in which it was invented and to a company that has the needed expertise in digital therapeutic development and validation as well as user engagement.  That company was Click Therapeutics, Inc. In 2016 Click Therapeutics licensed the EFMT technology from Mount Sinai for further development and validation, and ultimately to commercialize the technology and get it into the hands of MDD patients that need it.

Since joining Click Therapeutics as the Director of Scientific Affairs in 2016, I have been leading the company’s efforts to bridge the gap between the laboratory and the clinic. With the EFMT technology licensed to Click Therapeutics, it has undergone further development and refining at a much faster pace, and the path to disseminating EFMT as a standalone or combination treatment for MDD can be accelerated. Regarding the steps forward after these latest results, Click Therapeutics will now be advancing this program of research and development to the next level, by incorporating this treatment into a highly engaging mobile platform and evaluating the resulting digital therapeutic in an FDA registration study slated to commence by the end of 2018.

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