FDA Approves the First App to Treat Depression

The U.S. Food and Drug Administration has cleared Rejoyn, the first prescription-only app for the treatment of depression.

The app is intended for adults with the symptoms of major depressive disorder (MDD) who already receive clinician-managed outpatient care and who are on antidepressant medication.

Designed by Otsuka and Click Therapeutics, Rejoyn requires a prescription by a healthcare professional.

The six-week treatment program consists of three parts: cognitive behavioral therapy (CBT)-based lessons, cognitive and emotional brain training exercises, and personalized reminders and messaging.

Lessons and exercises, which last from three to 26 minutes daily, are intended to be done six times a week, with Saturday as a rest day. Once the six-week treatment period is over, users can revisit CBT-based lessons for an additional four weeks.

“While traditional approaches are often effective, many are left with only a partial response to treatment. Otsuka has a long, unwavering commitment to addressing the unmet needs of people living with mental illnesses and the clearance of Rejoyn is an example of delivering on that promise,” John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka, said in a statement.

Major depression is one of the most common mental illnesses in the United States, affecting more than 8% of American adults each year.

The condition is diagnosed when an individual has a persistently low or depressed mood, decreased interest in pleasurable activities, lack of energy, poor concentration, and appetite changes, among other symptoms.

Rejoyn reduced symptom severity

The FDA’s decision is based on a 13-week trial that involved 386 participants aged 22 to 64 with MDD and who were taking antidepressants.

They were randomized to receive either Rejoyn or a sham control app. Patients treated with Rejoyn showed an improvement in the severity of depression symptoms based on multiple patient and clinician-reported scales.

One month after completing the six-week treatment program, participants in the Rejoyn group showed continued improvement.

No side effects were assessed as related to Rejoyn during the trial. However, one person in the treatment group experienced worsening depressive symptoms.

Six participants in the Rejoyn group reported clinically important suicidality during the study period, compared to nine in the sham app group.

According to its manufacturer, the program works by targeting neural networks affected by depression and hypothesizes that leveraging the brain’s inherent neuroplasticity to alter those connections will lead to symptom reduction over time.

Rejoyn is expected to be available for download from app stores for iOS and Android operating systems in the second half of 2024.

The new FDA-approved app is intended to complement, not replace, clinical depression treatment. Discuss the possibility of using it with your healthcare provider.


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