FDA approves first prescription digital app to help treat major depressive disorder
INDIANAPOLIS (WISH) — The U.S. Food and Drug Administration this week approved a smartphone app, available by prescription, to help treat people diagnosed with major depressive disorder who are already using antidepressant medication.
Rejoyn, created by Otsuka Pharmaceutical and Click Therapeutics, is the “first prescription digital therapeutic authorized for the treatment of major depressive disorder,” according to a press release from the companies.
It will only be prescribed to those aged 22 years and older.
The companies describe it as a six-week treatment program. It helped to treat the symptoms of MDD by “enhancing cognitive control of emotion.” The companies said they used emotional training exercises and lessons based on therapy.
According to CNN, app users are asked to identify and compare emotions displayed on the screen. The exercises may stimulate the same parts of the brain that are involved in depression, which could have antidepressant effects.
CNN reported that Rejoyn, due to the way it is classified, only needed to prove that it was equivalent to another device given FDA approval to gain the clearance.
Major depression is one of the most common mental illnesses, according to Mental Health America, a group advocating for increased national awareness about mental health by utilizing public education, direct services, tools, and research.
The group said MDD affects more than 21 million American adults each year and 3.7 million kids and teenagers aged 12-17.
About 18% of American adults, which amounted to more than 1 in 6, said they were depressed or getting treatment for depression, CNN reported, citing a 2023 Gallup report.
“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” said Dr. John Kraus, executive vice president, and chief medical officer at Otsuka, in the release. “While traditional approaches are often effective, many are left with only a partial response to treatment.”
Rejoyn was cleared by the FDA based on data from a 13-week double-blinded, randomized, and controlled trial of 386 participants between the ages of 22 and 64, the press release said. Participants had been diagnosed with MDD and were taking antidepressant medication.
Those treated with Rejoyn showed an improvement in depression symptoms, according to the press release.
Rejoyn will be available for download from app stores in the latter half of 2024.