The news release describes an interesting new technology that uses computer technology to try to “rebalance” activity in regions in the brain of depressed patients towards normal patterns by having them repeatedly do a task involving identifying moods on faces. Industry connections were clearly established, which is good. But many details are missing: How many people were in the study? How severe was their depression before and after? What were the limitations? Any adverse events?
We need more and better ways of treating depression, which is one of the chronic diseases that disables millions of U.S. adults. But this release does not go far enough to help readers assess this new therapy’s potential, nor how it might compare to existing techniques such as drugs and psychotherapy.
There is no mention of costs. The release would have been stronger if it allowed readers to see the economic context of this new therapy.
The release provides only percentages, with no actual numbers for the patients who did and did not receive the therapy. We don’t know if it was 10 patients or 10,000 patients. We also don’t know how the symptoms were measured, nor how severe the depression was in the two groups at baseline and afterward. (We looked up a presentation of the study: It had just 26 people.)
Excerpt: “In the trial, the therapeutic reduced MDD symptoms by 42 percent in the experimental group after six weeks compared to 15.7 percent in the control group, which was given a similar task using simple shapes instead of emotions.”
Also: If the groups received therapy for six weeks, how often did they receive it each week? What was the control group receiving? Was it once for 45 minutes or twice a week for 30 minutes? All these details would help us understand this.
We found just one comment. Excerpt: “The initial results demonstrate that the efficacy of this digital therapeutic is comparable to drug therapy, with a highly favorable safety profile.”
Each drug shows different efficacy, so we’re not sure how this was established. Also, it’s standard to track adverse events in trials. For this one, what adverse events did the researchers find? We’re not told.
The news release doesn’t adequately establish the quality of the evidence. Specifically, that because the research has not been published in a journal, it is preliminary. It’s also worth pointing out that six weeks is a short timeframe to measure the effectiveness of a treatment for a chronic disorder.
There is no disease mongering.
We were glad to see the for-profit entity, Click Therapeutics, clearly labeled as a contributor to the research and employer of at least one of the investigators.
But we would have liked a clearer explanation of conflicts. Do any of the study authors participate in patents related to this work? How might researchers benefit financially? The study presentation does disclose they hold patent applications.
“Mount Sinai Innovation Partners (MSIP), the commercialization-arm of the Icahn School of Medicine at Mount Sinai, has been a key partner in this development.”
Many other therapies for major depression have been developed, and some of them use technological approaches. Besides these, there are also drugs, psychotherapy and exercise with known benefits. The release would have been stronger if it had listed some of what is already known to work, and explained how the new therapy fit into that context. Is it cheaper? More effective? Easier for rural patients to access?
Because the release is about a new therapy, we assume it is not available outside of a clinical study yet.
The release establishes the novelty about this technology. Although we think this could have waited until a large, randomized study had been completed–and peer-reviewed–before they publicized the work.
Some of the language appeared to swerve into exaggeration but was not unjustifiable.