October 14, 2021
1 min read
Prescription digital therapeutic company Limbix announced the launch of a digital tool for teens and young adults with depression symptoms.
The therapeutic, SparkRx, incorporates cognitive behavioral therapy and is meant to serve as an adjunct treatment for individuals aged 13 to 22 years.
“Today’s youth are experiencing unprecedented mental health challenges,” Benjamin Alouf, MD, chief medical officer at Limbix, said in a press release. “There is a shortage of timely treatment options to get them the help they need, when they need it the most.
“SparkRx provides an immediate, safe, self-guided and private treatment option for teens and young adults,” Alouf added. “I’m hopeful that SparkRx can help teens, as well as pediatricians, family practitioners, therapists, school counselors — anyone serving as a first line of defense for teens who need mental health care.”
Youth can access SparkRx via a health care provider and at no cost, for a limited time. The therapeutic is available on a smartphone and offers treatment in a 5- to 7-week period. It guides users through mood tracking, behavioral activation, problem solving and mindfulness and features a supportive robot guide. Adolescent psychology experts aided in the design of Spark Rx, according to the release.
Patients in the necessary age range will be able to use SparkRx under the FDA’s Enforcement Policy for Digital Health Devices Treating Psychiatric Disorders During the COVID-19 Public Health Emergency. The therapeutic has not received FDA clearance or approval, and the FDA has not validated trial results related to its safety or efficacy. Limbix noted plans to pursue full FDA regulatory review of SparkRx.
Results recently presented at the American Academy of Pediatrics National Conference & Exhibition Virtual Experience showed that among 83 participants who completed the program as recommended, there was a statistically significant reduction in depression symptoms compared with an active control app. Results also showed a 21% remission rate for SparkRx vs. a 4% remission rate for control at the end of treatment.
“The results of our clinical trial are promising and underscore the potential in designing scientific programs that providers can leverage to treat adolescents with symptoms of depression,” Jessica Lake, PhD, chief science officer at Limbix, said in the release. “Our clinical trial provides us valuable insights [that] will allow Limbix to continue to pursue regulatory pathways to FDA clearance.”