FDA Clears Prescription Digital Therapeutic for Adults with Major Depressive Disorder

,

 / 

Prescription Digital Therapeutic

The FDA has recently cleared a groundbreaking prescription digital therapeutic, known as Rejoyn, for the treatment of major depressive disorder (MDD) symptoms in adults. This innovative therapy, developed by Otsuka Pharmaceutical Co. Ltd. in collaboration with Click Therapeutics Inc., aims to provide adjunctive care for individuals who have been prescribed antidepressants as part of clinician-managed outpatient treatment.

Rejoyn is a 6-week treatment program designed to assist individuals aged 22 years and older in regulating their emotions through a combination of clinically validated cognitive training exercises and therapeutic lessons.

The therapy utilizes digital platforms to deliver personalized brain-training exercises, aiming to improve connections in brain regions affected by depression.

Dr. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, expressed enthusiasm about Rejoyn’s potential impact on addressing MDD symptoms. He highlighted the therapy as a novel adjunctive treatment option that complements the existing standard of care. Despite the effectiveness of traditional approaches, many individuals with MDD still experience only partial responses to treatment.

The FDA clearance of Rejoyn was based on data from the Mirai study, a 13-week, double-blinded, randomized, controlled trial involving 386 adults diagnosed with MDD. Participants, aged 22 to 64 years, who exhibited an inadequate response to antidepressants were enrolled in the study.

They were randomized to receive either Rejoyn or a sham control app for 6 weeks, with the primary efficacy endpoint being the change in the Montgomery-Åsberg Depression Rating Scale from baseline to week 6.

Results from the Mirai study demonstrated significant improvements in depression symptom severity among participants in the Rejoyn group compared to the control group. These improvements were consistently observed across various patient and clinician-reported scales, including the Patient Health Questionnaire nine-item depression scale and the Clinical Global Impression – Severity scale.

Furthermore, participants who underwent the Rejoyn treatment continued to experience sustained improvement in depression symptoms even one month after completing the program.

Dr. Brian Iacoviello, an assistant professor at the Icahn School of Medicine at Mount Sinai and scientific adviser at Click Therapeutics, elaborated on Rejoyn’s neuromodulatory mechanism. He likened the therapy to physical therapy for the brain, delivering personalized brain-training exercises to enhance brain connectivity in regions affected by depression.

The FDA clearance of Rejoyn marks a significant milestone in the treatment landscape for MDD, offering a promising adjunctive therapy option for individuals struggling with depression symptoms. With its innovative approach and demonstrated efficacy, Rejoyn has the potential to enhance patient outcomes and expand the range of treatment options available for MDD.


— Share —

— About the Author —

Leave a Reply

Up Next

New Study Reveals Link Between Depression, Anorexia, and Gut Microbiota

Prescription Digital Therapeutic

A recent study published in BMC Psychiatry sheds light on a potential connection between major depressive disorder (MDD), anorexia, and gut microbiota. Led by researchers at the First Hospital of Shanxi Medical University, the study suggests that individuals with both depression and anorexia exhibit distinct patterns in their gut bacteria, particularly involving the presence of a specific bacterium called Blautia.

Depression, characterized by persistent sadness and a loss of interest in daily activities, affects millions worldwide and is often accompanied by a high risk of suicide. Anorexia, marked by reduced appetite and distorted body image, commonly co-occurs with depression, complicating treatment efforts.

Gut Bacteria’s Role in Depression and Anorexia

Up Next

Anxiety Alleviation: Dietitians Recommend 4 Drinks to Lower Anxiety

Prescription Digital Therapeutic

In a world where stress and anxiety are prevalent, with up to 19% of U.S. adults experiencing prolonged anxiety, the quest for effective coping mechanisms continues.

While traditional treatments like medication and therapy remain pillars of support, emerging research suggests that dietary choices, including hydration, might play a significant role in managing anxiety levels.

Drinks to Lower Anxiety You Must Know About

Here, we delve into the top drinks to lower anxiety recommended by dietitians –

1. Chamomile Tea: Renowned for its calming properties, chamomile tea contains apigenin, a flavonoid compound known for its anti-anxiety effects. Wan Na Chan, M.P.H., RD,

Up Next

Managing Autoimmune Disorders Through Yoga: Effective Practices to Consider

Prescription Digital Therapeutic

In recent years, the intersection between holistic practices like yoga and conventional medicine has garnered significant attention, particularly in the realm of managing autoimmune disorders.

A burgeoning body of research suggests that incorporating yoga into treatment plans can offer tangible benefits for individuals grappling with autoimmune conditions. From rheumatoid arthritis to lupus, yoga’s gentle yet powerful techniques hold promise in alleviating symptoms and improving overall quality of life.

Yoga, with its emphasis on mindful movement, breathwork, and relaxation, provides a multifaceted approach to managing autoimmune disorders. The practice not only addresses physical symptoms but also targets the underlying stress and inflammation that often exacerbate these conditions.

Up Next

Pregnancy Linked to Accelerated Aging Process in Women, Study Finds

Prescription Digital Therapeutic

In a recent study published in the Proceedings of the National Academy of Sciences, researchers shed light on a compelling connection between pregnancy and the aging process in women.

The study, led by Calen Ryan, an associate research scientist at the Columbia University Ageing Center, suggests that women who have experienced pregnancy may exhibit more signs of biological aging compared to those who haven’t. Intriguingly, the research also indicates that the aging process may accelerate with multiple pregnancies.

Ryan commented on the findings, stating, “We’re discovering that pregnancy leaves lasting effects on the body. While not all are negative, it appears to heighten the risk of certain diseases and overall mortality.”

Stud

Up Next

Unlocking Hoarding Disorder: Understanding, Support, and Effective Solutions

Prescription Digital Therapeutic

Hoarding disorder, a mental health condition characterized by persistent difficulty in parting with possessions and accumulating excessive clutter, affects millions of individuals worldwide. Here’s what you need to know about this often misunderstood disorder and how to support those who struggle with it.

Defining Hoarding Disorder:

Hoarding disorder is a complex mental health condition marked by a compulsive urge to accumulate possessions, leading to overwhelming clutter and difficulty discarding items.

According to experts like Brad Schmidt and Gregory Chasson, individuals with hoarding disorder often experience distress at the thought of parting with their belongings and may also have a strong desire to acquire new items.

Up Next

Understanding Cherophobia: Signs, Causes, and Coping Strategies

Prescription Digital Therapeutic

Cherophobia, a condition characterized by an aversion to happiness, has garnered attention for its impact on mental well-being.

Derived from the Greek word “Chairo,” meaning “I rejoice,” cherophobia manifests as an irrational fear of experiencing joy. Therapist Carolyn Rubenstein explains that this fear often stems from anxious thoughts associated with past trauma or childhood experiences linking happiness to negative outcomes.

Signs of Cherophobia

Recognizing the signs of cherophobia is crucial for identifying individuals who may be struggling with this condition:

Feelings of Guilt and Unworthiness: Those with cherophobia experience guilt and unwor

Up Next

Stress Can Lead to Cortisol Belly: Here’s How to Fix It

Prescription Digital Therapeutic

Stress can affect our lives in many ways, from our mental health to our relationships, but it can also lead to physical symptoms such as ‘cortisol belly’. Cortisol belly, named after the stress hormone, has been widely discussed on social platforms such as TikTok, with users and experts explaining how it occurs, and theorizing what could be done about it.

While you may not have heard of the term ‘cortisol belly’ before, you might have heard of stubborn belly fat or stress belly, which are essentially the same thing. This is because it refers to the accumulation of visceral adipose tissue around the stomach, which has been linked to prolonged exposure to elevated levels of the stress hormone, cortisol.

What Is Cortisol Belly?

According to dietitian