Today, Limbix, a prescription digital therapeutic company developing mental health treatments for adolescents, announced positive results from a virtual randomized controlled trial of SparkRx, the company’s digital therapeutic for adolescents with symptoms of depression.
For participants that completed the program as recommended (n = 83), SparkRx led to a statistically significant reduction in depression symptoms compared to an active control app (p = 0.023) and a 21% remission rate compared to a 4% remission rate for control at the end of treatment. Treatment response rates were 29% and 16%, respectively, for SparkRx and control.
Across the full study sample of 121 participants with moderate to severe depressive symptoms, adolescents randomized to SparkRx showed a clinically meaningful reduction in depression symptoms. At the end of the study, 24% of SparkRx participants had a treatment response and 17% were in remission. The intention-to-treat analysis comparing SparkRx to control was not significant (p = 0.07).
No participants experienced a serious adverse event or an unanticipated adverse device effect.
The data are being presented at the 2021 American Academy of Pediatrics National Conference by Benjamin Alouf, M.D., chief medical officer of Limbix, in a poster presentation titled “A CBT-based Digital Therapeutic is Effective in Reducing Symptoms of Depression in Adolescents.”
“At a time when more than one in five young people are struggling with depression, suicide attempts are rising, and we have a critical shortage of mental health specialists, SparkRx is an evidence-based solution that primary care providers can immediately offer their patients,” said Dr. Alouf. “We are very encouraged by these promising results and believe that SparkRx has the potential to address the growing mental health crisis in the U.S. and the need for improved access to treatment for our youth. Supported by our positive results, we are launching SparkRx and making it available for a limited time at no cost to patients or providers.”
In a separate announcement today, Limbix announced the launch of SparkRx under the U.S. Food and Drug Administration’s (FDA) Enforcement Policy for Digital Health Devices Treating Psychiatric Disorders During the COVID-19 Public Health Emergency. Care providers interested in offering SparkRx to their patients should register at https://www.sparkrx.com/.
SparkRx has not been cleared or approved by the FDA, nor have these trial results been validated by the FDA with regard to the safety or efficacy of SparkRx by Limbix. Limbix intends to pursue full FDA regulatory review of SparkRx. The company is working with payers to establish reimbursement to ensure SparkRx is as accessible to patients as possible should it receive FDA clearance. Patient financial support programs will also be made available for those who qualify.
About the Clinical Trial
The clinical trial is phase II of a registered clinical study (NCT04524598) evaluating the clinical efficacy and safety of Limbix SparkRx in adolescents (13-21) with depressive symptoms. A total of 160 adolescents aged 13-21 with self-reported symptoms of depression were enrolled in this phase of the study, with data from 121 participants with moderate to severe depressive symptoms analyzed. The primary endpoint of the study was change in depression symptoms from baseline. Secondary endpoints included change in anxiety symptoms and change in parent report of child depressive symptoms from baseline. Study enrollment has closed and analysis of the primary endpoint has been completed.
Limbix SparkRx is a cognitive behavioral therapy-based digital therapeutic program for teens and young adults experiencing symptoms of depression. SparkRx provides clinicians with an immediate, safe and private adjunct treatment option to offer their patients. SparkRx, which was made to be completed over the course of multiple weeks, aims to overcome common barriers to mental health care accessibility and meet young people in a comfortable format – their smartphone. The self-guided program teaches skills like mood tracking, behavioral activation, problem solving and mindfulness. Limbix’s interdisciplinary team designed SparkRx alongside subject matter experts in adolescent psychology with the scientific rigor, clinical expertise and digital innovation needed to set it apart in the field.
For more information about SparkRx or to register to offer SparkRx to patients, please visit SparkRx.com/.
Limbix is a prescription digital therapeutic company passionate about creating mental health treatments for adolescents. The Limbix team is uniquely suited to develop prescription digital therapeutics, as its diverse team of clinicians, product designers, researchers, and engineers understand the value of pairing clinical expertise with technological innovation. Their first digital therapeutic, Limbix SparkRx, is now available for licensed health care professionals to offer to patients nationwide.
For more information about Limbix please visit limbix.com.