Limbix, a company founded in 2016, which creates digital therapeutics for adolescents, has released data from a trial on a Smartphone app it developed called SparkRx.  Limbix's app is a self-guided therapy program specifically designed for adolescents.  The company has raised $9 million in Series A funding (a platform that closed in May 2020).  Investors for the company include Sequoia Capital, Storm Ventures, NextGen Venture Partners, and BIXINK Therapeutics.Limbix's SparkRx, is meant to help teens manage mental health symptoms, especially those associated with depression.  The app is the first of the company’s products to be evaluated clinically and encourages teens to take note of their symptoms, while helping them to schedule activities to make them feel better.“They’re only really intended to spend a few minutes a day with it,” said Limbix’s Chief Medical Officer, Benjamin Alouf, who explained how the clinical trial was set up.  He said, “[Teens use it] to schedule, to plan, to set the stage, and then to go out and do this activity.  Then they report back as to how it went.” The results were presented at the 2021 American Academy of Pediatrics National Conference and Exhibition Virtual Experience.

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The study included 160 individuals ages 13-22.  They were split into groups and asked to either use SparkRx or another app that provides mental health education.  The participants were diagnosed with mild to severe depression and were symptomatic, and the level of their depression was evaluated based on a standard PHQ-8 questionnaire.SparkRx was associated with “a decline in PHQ-8 scores among teenagers,” according to the team’s findings, with an overall drop in scores of approximately five points, making the results clinically significant.  The team noted that the drop wasn’t statistically significant on its face, however, compared to a control group who received only mental health education. Rather, the team found SparkRx led to clinically significant results with those teens who filled out the PHQ-8 questionnaires every week (not everyone in the treatment group did).  Among those who did, the app clearly outperformed the control group’s results.After five weeks, “21 percent of teens who followed all of the study’s steps were in remission from depression, compared to four percent of the control group,” according to the presentation.  Interestingly, the trial showed a higher-than-average retention rate when it comes to mental health apps, overall.  “Forty-two percent of teens used the app every day compared to 19.5 percent seen in other research depression apps,” the team noted.  On average, the users “completed about 63.5 percent of the program.”Because the Food and Drug Administration (FDA) is allowing for any and all mental health programs to be released without objection during the pandemic, SparkRx can be prescribed by healthcare providers right now to teens for whom doctors feel it will aid in their treatment.Alouf said, “We have found through our studies, and it’s also been published, that adolescents prefer a self-guided, somewhat autonomous and very, very discrete methods of therapy.  They like to do it on their own time, at their own convenience and at their own pace.”  Thus, a self-guided app like SparkRx is a good option.

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Limbix releases clinical trial data on a self-guided mental health app for teensLimbix Presents Data Demonstrating Treatment with SparkRx Digital Therapeutic Results in Clinically Meaningful Reductions in Depressive Symptoms in AdolescentsDigital therapeutics for adolescent mental health