The FDA has approved Rejoyn, a smartphone app developed by Otsuka Pharmaceutical and Click Therapeutics, as the first prescription digital treatment for major depressive disorder in the United States.
Rejoyn is intended for adults aged 22 and older who are diagnosed with major depressive disorder and are already undergoing treatment with antidepressant medications.
Driving the news: The app utilizes a six-week program combining cognitive-emotional training and cognitive behavioral therapy lessons, designed to complement the standard treatment by targeting partial responders to antidepressants.
- The cognitive-emotional training approach used in Rejoyn, specifically the Emotional Faces Memory Task, aims to stimulate brain regions associated with depression and has neuromodulatory effects by delivering personalized brain-training exercises.
- The FDA clearance for Rejoyn was based on a clinical trial involving 386 participants, which showed an improvement in depressive symptoms, though not significantly different from a sham app in the trial. No side effects were reported in the study.
- Rejoyn is made by Otsuka Pharmaceutical and Click Therapeutics.
What they’re saying: “Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” Dr. John Kraus, executive vice president and chief medical officer at Otsuka, said in a press release. “While traditional approaches are often effective, many are left with only a partial response to treatment.”
