The US Food and Drug Administration (FDA) has approved the first-ever prescription app for major depressive disorder (MDD).
The app, Rejoyn, was developed by Otsuka Pharmaceutical and Click Therapeutics. It will be available by prescription only to adults aged 22 years or older, under the care of a clinician, who are already taking antidepressant medications. The companies expect the app to be available for download later in 2024.
“The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder,” said David Benshoof Klein, co-founder and chief executive officer at Click Therapeutics, in a statement. “It provides hope for those who are looking for new treatment options, especially one that is easily accessible through the device in the palm of your hand,” he said.
John Torous, MD, MBI, assistant professor of psychiatry at Harvard Medical School and director of the Digital Psychiatry Division at Beth Israel Deaconess Medical Center, said the pivotal study submitted for FDA approval was well-conducted, but did not show an overwhelming treatment effect for Rejoyn.
People using Rejoyn “definitely got better,” he told Medscape Medical News. However, “people using a sham version also had this seemingly equivalent improvement as well,” he said.
Given that it’s an adjunctive and not a standalone treatment, and poses minimal risk, “perhaps we’ll all find out what the benefits are if people start using it,” said Torous.
Rejoyn provides 6 weeks of treatment broken into cognitive-behavioral therapy (CBT)–based lessons, emotional faces memory task (EFMT) exercises, and personalized reminders and messaging. CBT-based lessons are available for review for 4 weeks beyond the initial 6-week period.
The FDA approved Rejoyn based on data from the Mirai study, a 13-week multicenter, remote, double-blinded, randomized, controlled trial with 386 participants, aged 22-64 years, who had been diagnosed with MDD and were on antidepressant medication.
The primary analysis looked at 177 people who used Rejoyn and 177 who used a sham treatment app and who had one session with either treatment and assessments of the Montgomery-Asberg Depression Rating Scale (MADRS) total score at both baseline and at least one post-baseline timepoint.
Participants in both groups received personalized reminders and text messages throughout, and visits were conducted remotely by video or telephone. Adherence to exercises was monitored.
As described in Rejoyn’s clinician brief summary, the mean change from baseline in the MADRS total score was -9.03 in the Rejoyn group compared with -7.25 in the sham group (P = .0568; 95% CI, -3.60 to 0.05), which was not statistically significant. The final P value did not meet the prespecified threshold of.049.
There were no serious treatment emergent adverse events or discontinuations due to an adverse event in patients using Rejoyn.
It’s unclear why the companies pursued a prescription-only app, although it could be a bid to get it covered under health insurance. Click and Otsuka had not responded to a Medscape Medical News request about these issues by press time.
Torous pointed out that a clearing house run by his team, Mindapps.org, lists close to 600 mental health apps, most of which are free or cost less than $10. None are FDA-approved, but “there’s no reason why someone couldn’t take one of these apps and talk to their clinician about it,” he said.