FDA Clears First Digital Treatment for Depression, Rejoyn, with Caution from Experts
The US Food and Drug Administration has granted clearance for Rejoyn, marking the first-ever digital treatment for major depressive disorder. Developed by Otsuka Pharmaceutical and Click Therapeutics, Rejoyn is a smartphone app designed to complement antidepressant medications for individuals aged 22 and above diagnosed with major depressive disorder. This groundbreaking treatment utilizes a six-week program integrating cognitive-emotional training and cognitive behavioral therapy lessons.
Rejoyn’s approval represents a significant advancement in addressing major depressive disorder symptoms that persist despite traditional treatment methods. Dr. John Kraus, the executive vice president and chief medical officer at Otsuka, emphasized the app’s role as an adjunct to current standard care practices. He highlighted that while conventional approaches can be effective, many individuals experience only partial relief from symptoms.
Depression affects a substantial portion of the US population, with approximately 18% of American adults reporting depression or receiving treatment for the condition. Furthermore, up to 30% of individuals using antidepressant medications are considered partial responders, meaning they continue to experience depressive symptoms despite treatment.
Rejoyn aims to fill this treatment gap by serving as an adjunct to antidepressants for partial responders. The app employs a novel approach called cognitive-emotional training, featuring exercises like the Emotional Faces Memory Task. This task prompts users to identify and compare emotions displayed on faces, stimulating brain regions associated with depression, such as the amygdala and dorsolateral prefrontal cortex.
Dr. Brian Iacoviello, a scientific adviser at Click Therapeutics, explained that Rejoyn’s mechanism mimics physical therapy for the brain, facilitating improved connectivity in regions affected by depression. However, experts caution that this cognitive-emotional training approach is still exploratory, lacking extensive validation.
The FDA clearance for Rejoyn was based on a clinical trial involving 386 participants aged 22 to 64 with major depressive disorder unresponsive to antidepressants. Participants were randomized to use either the Rejoyn app or a sham app for cognitive tasks. While those using Rejoyn showed improvement in depressive symptoms, the difference compared to the sham app was not statistically significant. Nonetheless, no adverse effects were reported during the trial.
Despite the trial’s limitations, Otsuka Pharmaceutical is optimistic about Rejoyn’s potential. The company plans to explore additional research areas, including other indications and patient populations. Rejoyn is expected to be available for download with a prescription in late 2024, although insurance coverage remains uncertain.
Dr. John Torous, director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, underscored the importance of educating clinicians and patients about digital mental health tools. While Rejoyn may offer benefits for some individuals, it’s crucial to weigh the risks and benefits before recommending or prescribing such treatments.
As the field of digital therapeutics continues to evolve, stakeholders must prioritize evidence-based practices to ensure patient safety and efficacy. While Rejoyn represents a significant milestone, ongoing research and clinical evaluation will be essential in determining its long-term impact on depression treatment.
Maeva B.