United States – The US Food and Drug Administration, has cleared up the use of Rejoyn, the first digital and live prescription treatment for major depressive disorder.
Rejoyn’s Development
The Rejoyn smartphone app is developed by Otsuka Pharmaceutical and Click Therapeutics to integrate with antidepressants for people who are 22 years of age and older with a major depressive disorder diagnosis. It uses a 6-week program that combines a new method – called cognitive-emotional training – and cognitive behavioral therapy lessons, as explained in CNN news release.
Since the Rejoyn product has been named a low—to medium-risk medical device, it does not need strong evidence to be cleared. To acquire clearance, it just needed to prove to the FDA that it is “substantially equivalent” to some other marketed device (that is, it is just as safe and effective).
“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” Dr. John Kraus, executive vice president and chief medical officer at Otsuka, said in the release. “While traditional approaches are often effective, many are left with only a partial response to treatment.”
The US, one of the countries with the highest incidences of depression, is a mental health problem. However, no less than 18% of American adults – 1 out of 6 – are affected by depression or are taking care of it in 2023, according to the Gallup survey. Research has also revealed that a part of epimers could react partially with some patients, and up to 30% of people might not show a good response when they are using antidepressant medications.
The declared aim of Rejoyn is to serve as an additional therapy for those patients who are only partially responding to antidepressants, as announced in a news release. Using a form of cognitive-emotional training called Emotional Faces Memory Task, the app tests people by asking them to identify and compare expectations and actual feelings displayed on a series of faces. Studies have shown that these exercises may activate the amygdala (a part of the brain associated to depression) and the dorsolateral prefrontal cortex – regions of the brain known to prevent depression, and this may lead to antidepressant effects.
“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” Dr. Brian Iacoviello, scientific adviser at Click Therapeutics and a co-inventor of Emotional Faces Memory Task, as explained in CNN news release.
According to Dr. John Torous, the director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, who does not belong to the development group of Rejoyn, the process of emotional-cognitive training is not a well-established mechanism, and the research is still exploratory.
Clinical Trial Results and FDA Clearance
The FDA approval of Rejoyn was obtained as a result of the results of a clinical trial that enrolled a total of 386 people ages 22 to 64 with major depressive disorder that was not responsive to antidepressants. The participants were assigned either to Rejoyn or the control group to use an app that provided memory tasks that did not involve cognitive-emotional training and cognitive behavioral therapy.
The research reported that the only positive difference in using the Rejoyn app was that of symptom relief; however, this improvement was not significantly different from that caused by the Sham One with a sham app. In the trials, there were no side effects noted.
Torous pointed out that the trial didn’t prove that ‘Rejoyn’ has a statistically provable or absolute benefit. It was also designed for personal well-being rather than as a standalone treatment.
“If the benefit is minimal but the risks are minimal, perhaps there’s no harm in trying it,” he said. Hopefully, we will see more evidence in the future because, as a clinician psychiatrist, I want to make sure people use something that is going to make them better.”
Accessibility and Affordability
Otsuka Pharmaceutical reported that it is exploring additional avenues of study, such as investigating other treatment indications and patient populations, but did not comment on any particular subsequent clinical trials.
According to Huawei’s statement, Rejoyn will be available in late 2024 in stores with a prescription for download. Otsuka added that it would endeavor to make the product easily “accessible and affordable” for people but declined to mention the exact price.
In a testimony, Torous mentioned that insurance companies might reject insurance coverage for the app because it did not show importance in clinical trials. He highlighted the fact that even though the device is FDA-cleared, this does not mean automatic insurance approval of it as well.
“The next frontier is going to be educating everyone on the risks and benefits of these tools. Many clinicians may not be ready to begin prescribing,” he said.
It is not clear how patients will be involved in the app either. The Rejoyn findings showed that 88% of participants attended at least 12-18 appointments.
Numerous mental health applications that are meant for different types of mental disorders do not require a prescription to be used, Torous said. Doctors need to understand the specific needs and preferences of their patients before recommending a digital tool, he said, as reported by CNN.
“I think that patients and clinicians are curious and excited to learn more, but both want to understand the risks and benefits,” Torous said. “There is an opportunity cost if you do something that is ineffective.”