Until now, treatments for clinical depression primarily fell into two categories: psychotherapy and antidepressant medications. However, this year the U.S. FDA approved the first app-based therapy for major depressive disorder, now available as of this summer.
U.S. Food and Drug Administration (FDA) has granted clearance to Rejoyn, the first prescription-based digital treatment for major depressive disorder (MDD). Created by Otsuka Pharmaceutical and Click Therapeutics, Rejoyn is a smartphone app designed to be used alongside antidepressant medication, aimed at adults aged 22 and older with MDD. The app utilizes a unique combination of cognitive-emotional training and cognitive behavioral therapy (CBT) over a six-week period to support partial responders to medication – those who still experience depressive symptoms despite treatment.
Rejoyn offers a targeted approach for people who experience limited improvement from standard antidepressant treatments. Through cognitive-emotional training, the app employs an innovative technique called the Emotional Faces Memory Task. This feature requires users to observe and analyze emotions expressed on a series of faces, encouraging them to build awareness and resilience in managing their own emotional responses.
Rejoyn’s FDA clearance was granted based on a study with 386 adults aged 22 to 64, all diagnosed with major depressive disorder that had shown little improvement with antidepressants. Participants were either assigned to use Rejoyn or a “sham” app that did not feature cognitive-emotional training or CBT. The trial found some improvement in depressive symptoms among Rejoyn users, but the differences were not statistically significant compared to the sham app. Importantly, no adverse effects were reported, making Rejoyn a low-risk option for users.
FDA’s clearance of Rejoyn does not equate to a declaration of the app’s clinical efficacy but is based on Rejoyn’s safety and similarity to other digital therapies already on the market.
Article written by Alice Park
24/10/2024
Source:
Time