Rejoyn: A Fundamental Change in How Clinicians Can Treat MDD Symptoms

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CLINICAL CONVERSATIONS

Rejoyn (CT-152) recently became the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication. Rejoyn is expected to be available for download later in 2024. In the meantime, Psychiatric Times sat down with John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, to learn more.

PT: Can you describe Rejoyn in your own words? How and why is it effective?

John Kraus, MD, PhD: Rejoyn (developed as CT-152) is a 6-week treatment intended to reduce MDD symptoms, delivered via smartphone app.

Rejoyn is designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. In the Mirai study, individuals treated with Rejoyn showed an improvement in depression symptoms from baseline. Symptom improvement was observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). One month after completing the 6-week treatment program, Rejoyn participants’ symptoms showed continued improvement. No side effects were assessed as related to Rejoyn during the trial.

PT: Tell us a bit about the cognitive emotional training exercises included in Rejoyn’s 6-week program. Why is this approach novel?

Kraus: Rejoyn offers a novel approach to the treatment of depression symptoms as it is designed to target neural networks affected by depression and is hypothesized to leverage the brain’s inherent neuroplasticity to alter those connections leading to symptom reduction over time. It introduces clinically-validated cognitive emotional brain training exercises (“Emotional Faces Memory Task” or “EFMT”) that were conceived and conceptually proven by a team of psychologists, psychiatrists, and neuroscientists. These brain exercises are designed to target and help alter those neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression.

For your reference, Rejoyn’s 6-week treatment program is composed of:

1. Clinically-validated cognitive emotional training exercises for the brain, which are designed to target and help alter the neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression. A neuromodulatory mechanism acts 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 symptoms. By creating stronger connections, the parts of the brain responsible for emotions and regulating emotions are better able to work together to process those emotions more appropriately.

2. Brief therapeutic lessons to teach skills that can help manage depression symptoms, including handling strong emotions, reframing negative thinking, and engaging in positive actions.

3. In-app notifications and SMS messages to reinforce lesson content and encourage engagement with the treatment program.

PT: How is it different from traditional cognitive behavioral therapy?

Kraus: While the 18 brief video lessons in Rejoyn are based on principles of cognitive behavioral therapy (CBT), including behavioral activation, cognitive restructuring, and emotional regulation, they are not the main component of Rejoyn’s 6-week treatment program and do not replace a course of manualized CBT with a trained clinician.

The main component of Rejoyn’s program, accounting for over 75% of the treatment plan time, are cognitive emotional training exercises.

PT: What do you think clinicians need to know about this digital therapeutic?

Kraus: While traditional approaches are often effective, many are left with only a partial response to treatment.

For some individuals with depression, the parts of the brain responsible for emotion recognition and processing and the parts responsible for cognition are thought to not communicate properly, thereby making emotional regulation more difficult.

Rejoyn was developed to target neural networks implicated in depression, potentially addressing a cause of disease that other treatments do not.

Many patients diagnosed with depression and who receive antidepressant medications or psychotherapy do not achieve an adequate response. These patients need new options that capitalize on proven-effective treatment strategies.

PT: What differentiates Rejoyn from say a mental health app, or other available digital therapeutics?

Kraus: Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a health care professional.

PT: How do you anticipate this treatment will change the landscape MDD treatment?

Kraus: It is estimated that 280 million individuals in the world have depression, with 21 million in the United States alone. Data suggests several individuals experiencing MDD symptoms do not receive any treatment at all. And, even when they do receive traditional approaches, many are left with only a partial response to treatment. Many patients diagnosed with depression and who receive antidepressants or psychotherapy do not achieve an adequate response. The clearance of Rejoyn signals a fundamental change in how clinicians can treat MDD symptoms.

PT: When can clinicians expect to see this treatment available to patients?

Kraus: Rejoyn requires a prescription from a health care provider and is expected to be available for download from app stores for iOS® and Android™ operating systems Summer 2024. To learn more about Rejoyn and sign up for updates regarding its availability, go to www.rejoyn.com. Health care providers can visit www.rejoynhcp.com.

PT: Are there any other products Otsuka has in development that you are excited about?

Kraus: We are currently focused on the successful launch of Rejoyn and have no additional information to share at this time.

PT: Thank you!

Dr Kraus is executive vice president and chief medical officer at Otsuka.