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It is the US Food and Drug Administration. Allowing Use of Rejoyn, the first prescription digital therapy for major depressive disorder.
Developed by Otsuka Pharmaceuticals and Click Therapeutics, ReJoin is a smartphone app intended to be used alongside antidepressant medications for people age 22 and older with major depression. It uses a six-week program that combines cognitive-emotional training with a new approach called cognitive-behavioral therapy. News release.
Because ReJoin is classified as a low-to-moderate-risk medical device, it only needed to prove that it was “substantially equivalent” to another marketed device to get FDA approval.
“ReJoin represents a new and exciting adjunctive treatment option to address the symptoms of major depressive disorder that complement the current standard of care,” said Dr. John Krause, Otsuka's executive vice president and chief medical officer, in the release. “While traditional approaches are often effective, many remain only partially responsive to treatment.”
Depression is one of the most common mental health disorders in the US. About 18% of American adults — 1 in 6 — report being depressed or receiving treatment for depression. 2023 Gallup report found. Research In addition, up to 30% of people who take antidepressants are partial responders, meaning they continue to have symptoms of depression. When using the drugs.
Rejoin is designed to serve as an adjunct to these partial antidepressants, the news release said. The app uses a type of cognitive-emotional training in which people are asked to identify and compare emotions displayed on a series of faces. Primary research These exercises show that the amygdala and dorsolateral prefrontal cortex – brain regions thought to be involved in depression – can have an antidepressant effect.
“ReJoin has a neuromodulatory approach designed to act as a mind-physical therapy, providing individualized and continuous brain training exercises designed to improve connections in brain regions affected by depression,” said Dr. Brian Iacoviello, scientific advisor to Click Therapeutics, co-inventor of the Emotional Memory Task, in a news release.
Dr. John Torres, director of the digital psychiatry division at Beth Israel Deacon Medical Center, who was not involved in ReJoin's development, said this cognitive-emotional training approach is not a well-proven method and research is still ongoing. descriptive.
The FDA's approval of Rejoin was based on the results of a clinical trial of 386 people aged 22 to 64 with major depressive disorder who had not responded to antidepressants. They were assigned to either the ReJoin app or a sham app that provided memory tasks that did not include cognitive-emotional training or cognitive-behavioral therapy.
of Research Although participants using the ReJoin app showed improvement in anxiety symptoms from baseline, the mean change was not significantly different from the change seen with the sham app. No side effects were recorded in the experiment.
Torres said the trial did not prove that ReJoin had a statistically significant benefit, but the app was not designed to be a stand-alone treatment.
“If the benefit is small but the harm is small, maybe there's no harm in trying it,” he said. “Hopefully, we'll see more evidence come out in the future, because as a clinical psychiatrist, I want to make sure people are using something that makes them better.”
Otsuka Pharmaceutical is evaluating additional research areas, including other indications and patient populations, but has not listed any specific follow-up studies.
Be happy It requires a prescription to download and will be available in late 2024, according to the news release. Otsuka said he would try to make the device “accessible and affordable,” but did not specify the price.
Insurance companies may cover the app because it hasn't shown significant impact in clinical trials, Torres said. FDA approval does not guarantee insurance coverage.
“The next frontier will be educating everyone about the risks and benefits of these devices. Many clinicians may not be ready or willing to start prescribing,” he said.
There's also the question of how patients will be on the app, Torres said. According to Rejoin's study, 88% of participants completed at least 12 of 18 treatment sessions.
Thousands of mental health apps They don't require a prescription, which is meant for various mental health disorders, Torres said. Doctors need to understand the specific needs and preferences of their patients before offering a digital device, he said.
“I think patients and clinicians are curious and eager to learn more, but they both want to understand the risks and benefits,” Torres said. “There's an opportunity cost if you do something ineffective.”