The US Food and Drug Administration has approved the utilization of Rejoyn, the inaugural prescription digital remedy for major depressive disorder.
Rejoyn, produced by Otsuka Pharmaceutical and Click Therapeutics, is a mobile application designed for utilization alongside antidepressant medications for individuals aged 22 and above who have been diagnosed with major depressive disorder. It incorporates a six-week regimen that amalgamates a novel approach termed cognitive-emotional training and cognitive behavioral therapy teachings, as outlined in a press release.
As Rejoyn falls into the category of low- to medium-risk medical devices, it only needed to demonstrate its "substantial equivalence" to another commercially available device – ensuring it is equally as safe and efficacious – to secure FDA clearance.
"Rejoyn presents an innovative and stimulating supplementary treatment alternative for addressing symptoms of major depressive disorder, complementing the current standard of care," remarked Dr. John Kraus, the executive vice president and chief medical officer at Otsuka, according to the release. "While conventional methods often yield results, many individuals experience only a partial response to treatment."
Depression stands as one of the most prevalent mental health conditions in the United States. According to a 2023 Gallup report, approximately 18% of American adults – over 1 in 6 – acknowledge experiencing depression or undergoing treatment for it. Additionally, research indicates that up to 30% of individuals prescribed antidepressant medications exhibit partial responses, indicating persistent depressive symptoms despite medication usage.
Rejoyn is crafted to function as a supplement to antidepressants for individuals experiencing partial responses, as stated in the press release. The application employs a variant of cognitive-emotional training known as the Emotional Faces Memory Task, wherein individuals are tasked with identifying and comparing emotions depicted on a series of faces. Initial studies suggest that these exercises may activate the amygdala and the dorsolateral prefrontal cortex – brain regions believed to play a role in depression – thereby exerting antidepressant effects.
"Rejoyn operates on a neuromodulatory principle, akin to physical therapy for the brain, offering personalized and consistent brain-training exercises aimed at enhancing connections in the brain regions affected by depression," noted Dr. Brian Iacoviello, scientific advisor at Click Therapeutics and a co-creator of the Emotional Faces Memory Task, in the press release.
Dr. John Torous, head of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, who was not associated with the development of Rejoyn, remarked that this approach to cognitive-emotional training is not yet firmly established and that ongoing research remains exploratory.
The FDA clearance for Rejoyn was granted based on findings from a clinical trial encompassing 386 individuals aged 22 to 64 diagnosed with major depressive disorder unresponsive to antidepressants. Participants were randomly allocated to utilize either the Rejoyn app or a placebo app offering memory tasks devoid of cognitive-emotional training or cognitive behavioral therapy.
Results indicated that although participants utilizing the Rejoyn app demonstrated a reduction in depressive symptoms compared to baseline, the average improvement was not notably distinct from that observed with the placebo app. Notably, no adverse effects were reported during the trial.
Torous emphasized that while the trial did not establish a statistically significant advantage for Rejoyn, it's crucial to recognize that the app isn't intended to be a standalone therapy.
He commented, "Even if the benefit is marginal and the risks are minimal, there may be no harm in giving it a try. Hopefully, we'll see more data emerge in the future because, as a practicing psychiatrist, I want to ensure that people use interventions that genuinely contribute to their improvement."
Otsuka Pharmaceutical mentioned that it is exploring further avenues of research, including different indications and patient demographics, but did not delineate specific follow-up investigations.
Rejoyn will necessitate a prescription for download and is slated for release in late 2024, as per the press release. Otsuka expressed intentions to make the tool "accessible and affordable," although they did not specify the pricing details.
Torous highlighted that insurance coverage for the app might be uncertain due to its lack of significant efficacy demonstrated in clinical trials. He stressed that FDA clearance does not automatically translate to approval from insurance providers.
"The next challenge will be educating everyone about the advantages and disadvantages of these tools. Many healthcare professionals may not feel ready or equipped to start prescribing them," he remarked.
Furthermore, Torous raised the question of patient engagement with the app. According to the Rejoyn study, 88% of participants completed at least 12 out of the 18 treatment sessions.
Torous noted that there are thousands of mental health apps tailored to various disorders that do not require a prescription. He emphasized the importance for doctors to understand their patients' individual needs and preferences before recommending a digital tool.
"I believe patients and clinicians are eager to explore and learn more, but they both want to grasp the potential risks and benefits," Torous added. "There's an opportunity cost if you opt for something that proves to be ineffective."
