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FDA approves first prescription-only app for depression
Plenty of therapy and wellness apps on the market aim to close gaps in access to mental healthcare -- including cost, provider availability, and insurance roadblocks. However, since they're only minimally or self-regulated and not required to conduct clinical trials, they can't treat mental health disorders. Prescription digital treatments could change that.
On Monday, the FDA approved Rejoyn, a smartphone app designed to treat the symptoms of major depressive disorder. Created by Click Therapeutics, a company that makes software-based medical treatments, and Otsuka Pharmaceutical, Rejoyn is the first digital therapeutic for depression that the regulator has cleared.
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The FDA has approved a few other apps, like Pear Therapeutics' reSET, which targets substance use disorders. According to a release from Otsuka and Click, Rejoyn is meant to be used as a supplement to supervised care for adults 22 and older who take antidepressant medication and have been diagnosed with major depressive disorder.
Unlike therapy apps such as BetterHelp [Android, iOS] and Talkspace [Android, iOS] , which are available to download from the App Store, you'll need a prescription from a healthcare provider to access Rejoyn.
Oral depression medications are typically prescribed to treat neurochemical imbalances, but these are not the only cause of depression. The release states that depression can also be influenced by miscommunication between parts of the brain that recognize and regulate emotion. The companies said the Rejoyn app works by tapping into the brain's neuroplasticity, using what Click calls Emotional Faces Memory Task (EFMT). Deployed via a six-week program, EFMT is a set of brain-training exercises developed by neuroscientists, psychologists, and psychiatrists that target neural areas affected by depression.
"When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together," said Brian Iacoviello, Ph.D., in the release. Iacoviello is an assistant professor of psychiatry at the Icahn School of Medicine at Mount Sinai and a scientific advisor at Click.
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The FDA cleared Rejoyn based on a 13-week study of 386 people ages 22 to 64, in which participants showed improvement in their baseline depression symptoms when using it, as compared to a sham app. The trial also showed continuing improvement a month after treatment, and reported no side effects.
Rejoyn's FDA approval comes at a significant time. Depression is one of the most common mental health concerns in the country, and rates are on the rise among adults. A May 2023 Gallup survey found that 29% of US adults report being diagnosed with depression at some point in their lives, an almost 10% increase since 2015. Nearly 18% of respondents 18 and over (more than 1 in 6) reported being depressed or receiving treatment for depression.
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Digital therapies like Rejoyn could help broaden treatment options, though it's still too early to tell how effective they'll be, or whether insurance will cover them.
Otsuka and Click expect Rejoyn to be available for iOS and Android operating systems in late 2024. In the meantime, Click appears to be working on several other digital therapies for smoking cessation, schizophrenia, insomnia, migraines, and more.