MDLinxFDA Approves Depression-treating Phone App

FDA Approval of Rejoyn App Highlights Digital Therapeutics for Major Depressive Disorder, Signaling Broader Applications for Cognitive Behavioral Technologies in Mental Health Treatment

The Food and Drug Administration (FDA) has approved Rejoyn, a prescription app for the treatment of major depressive disorder (MDD) in adults. The app, designed as an adjunctive therapy to antidepressant medication, combines therapeutic exercises, emotional regulation training, and supportive texts. Clinical trials have demonstrated its efficacy in improving depression symptoms, making Rejoyn a noteworthy addition to the growing field of digital health treatments.

Key Points:

• Approval and Indication:
  • The FDA has approved the Rejoyn app for the treatment of major depressive disorder in adults.
  • Rejoyn is intended as an add-on therapy to antidepressant medications.
• Clinical Trial Outcomes:
  • In a 13-week controlled trial with 400 participants aged 22 to 64, those using Rejoyn alongside antidepressants showed significant improvement in depression symptoms.
  • Improvements were maintained one month post-treatment.
  • No side effects were observed during the trial.
• App Features:
  • Rejoyn integrates therapeutic exercises, emotional regulation training, and supportive texts.
  • It uses the Emotional Faces Memory Task (EFMT), which asks users to identify and recall emotions displayed on faces to balance brain activity and mitigate negative thoughts.
  • A six-week treatment program requires under two hours of engagement per week.
  • The app is available by prescription only, and each new treatment course requires a new prescription.
• Cost and Accessibility:
  • Although the cost of Rejoyn has not been disclosed, its creators aim to make it affordable and accessible.
• Discussion on App-Based Treatments:
  • App-based treatment for depression is relatively new, and further studies are needed to validate long-term benefits.
  • Concerns exist regarding increased screen time, but Rejoyn’s limited weekly use mitigates this risk.
  • The trend towards digital and telehealth treatments is expected to grow, with technology increasingly integrated into healthcare practices.
• Other FDA-Approved Digital Therapies:
  • The FDA has approved several other digital therapeutic apps, including:
    • reSET for substance use disorder (2017)
    • reSET-O for opioid use disorder (2018)
    • EndeavorRx for pediatric ADHD (2020)
    • NightWare for PTSD-related nightmares (2020)
    • Somryst for insomnia (2020)
• Future Developments:
  • BrainSee, an AI software for early detection of dementia, was recently approved by the FDA.
  • A digital therapy app for schizophrenia is currently undergoing clinical trials and has Breakthrough Device designation.

“Digital medicine represents a fundamental shift for healthcare. In the same way that digital payment platforms and online banking apps transformed financial services. The revolution of telehealth and digital healthcare will drive this change in medicine. In 10 years, medical practices will serve as a control center—monitoring, coordinating, and delivering care through technology. Consumers will view their phones as the center of their care.”
– Paul MacLellan, President of Medical Advantage, Part of TDC Group

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