April 9, 2024

FDA Clears Rejoyn: First Prescription Digital Therapy for Major Depressive Disorder

The US Food and Drug Administration has authorized the use of Rejoyn, marking a significant milestone as the inaugural prescription digital therapy for major depressive disorder.

Developed by Otsuka Pharmaceutical and Click Therapeutics, Rejoyn is a smartphone application designed to accompany antidepressant medications for individuals aged 22 and above diagnosed with major depressive disorder. The app implements a six-week program, combining a novel approach known as cognitive-emotional training with lessons from cognitive behavioral therapy, as outlined in an official press release.

Given its classification as a low- to medium-risk medical device, Rejoyn was only required to demonstrate its "substantial equivalence" to another existing device, ensuring comparable safety and efficacy to gain FDA clearance.

Dr. John Kraus, executive vice president and chief medical officer at Otsuka, hailed Rejoyn as an innovative adjunctive treatment option that complements the current standard of care. Despite the effectiveness of traditional approaches, many individuals still experience only partial relief from depressive symptoms.

Depression remains a prevalent mental health disorder in the US, with approximately 18% of American adults reporting depression or undergoing treatment, according to a 2023 Gallup report. Moreover, research indicates that up to 30% of individuals using antidepressants are considered partial responders, continuing to experience depressive symptoms despite medication.

Rejoyn aims to address this gap by serving as an adjunct to antidepressants, particularly for partial responders. The app utilizes cognitive-emotional training, such as the Emotional Faces Memory Task, wherein users identify and compare emotions displayed on faces. Preliminary research suggests that these exercises may stimulate brain regions implicated in depression, potentially yielding antidepressant effects.

Described by Dr. Brian Iacoviello, scientific adviser at Click Therapeutics, as having a neuromodulatory mechanism akin to physical therapy for the brain, Rejoyn delivers personalized brain-training exercises to improve connections in regions affected by depression.

Despite its innovative approach, skepticism remains regarding the efficacy of Rejoyn's cognitive-emotional training. Dr. John Torous, director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, emphasized that the mechanism is not firmly established, and further research is warranted.

FDA clearance for Rejoyn was based on a clinical trial involving 386 participants diagnosed with major depressive disorder that was unresponsive to antidepressants. Participants were assigned to either Rejoyn or a sham app lacking cognitive-emotional training or cognitive behavioral therapy.

Although participants using Rejoyn showed improvement in depressive symptoms compared to baseline, the average change was not significantly different from that observed with the sham app. Nonetheless, no side effects were reported during the trial.

While the trial did not establish statistically significant benefits, it's important to note that Rejoyn is not intended as a standalone treatment. Dr. Torous emphasized the minimal risks associated with Rejoyn, suggesting that its use might be considered, although insurance coverage remains uncertain.

Otsuka Pharmaceutical is exploring additional research areas, including other indications and patient populations, with plans to make Rejoyn available in late 2024. However, specific pricing details have yet to be disclosed.

Dr. Torous underscored the importance of educating clinicians and patients about the risks and benefits of such digital tools. He emphasized the need for personalized recommendations, considering the diverse landscape of mental health apps.

In conclusion, while the FDA clearance of Rejoyn signifies progress in digital mental health treatment, further research is essential to elucidate its efficacy and ensure informed decision-making among clinicians and patients alike.

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