FDA Clears the First Prescription App for Depression

Fact checked by Nick Blackmer

Key Takeaways

• The FDA has cleared a prescription mobile app to treat major depressive disorder.

• The app, called Rejoyn, is intended to be used as an adjunct treatment along with antidepressants and talk therapy.

• Mental health experts say it could be worth trying since most people are already using their phones frequently.

The Food and Drug Administration (FDA) has cleared the first “prescription digital therapeutic” smartphone app to treat major depressive disorder.

The app, called Rejoyn and developed by Otsuka America Pharmaceutical, is intended to be used as an adjunct treatment along with antidepressants and talk therapy.

“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, said in a press release.

This is the first prescription app for major depressive disorder. Previously, there have been several FDA-approved or cleared digital therapies to treat a range of mental health conditions, including substance abuse disorders.

Major depressive disorder is a mental disorder in which someone has a depressed mood or loss of interest or pleasure in daily activities for at least two weeks. Other symptoms include trouble with sleeping, eating, energy, concentration, or self-worth. About 21 million American adults have had at least one major depressive episode.

Related: How Long Do Depressive Episodes Last?

How Does Rejoyn Work?

The Rejoyn app is a medical device to be used along with antidepressant medication and talk therapy. Although Rejoyn is a mobile app, it requires a prescription from a healthcare provider. It’s a six-week treatment program designed to help enhance emotional control through training exercises for the brain.

When patients use Rejoyn, they’re given lessons and exercises to do six days a week. The app also uses short cognitive behavioral therapy lessons. The app employs a brain training exercise called Emotional Faces Memory Task, which helps patients alter necessary neural connections to process emotions and reduce symptoms of depression.

The FDA clearance is based on preliminary research that shows the exercises may help stimulate areas of the brain that are involved in depression and, as a result, have antidepressant effects.

Related: How to Deal With Depression in Different Ways

How Effective Is Rejoyn?

Based on a 13-week study, about half of the Rejoyn users achieved a full or partial response to the treatment compared to 38.7% of users in the group that used a “sham” app. Rejoyn users who adhered to the app—meaning completing at least 12 of the 18 treatment sessions—showed a more pronounced improvement than the sham group. The improvements were observed up to week 10 in the study.

Related: What Types of Therapy Are Helpful for Depression?

What Do Mental Health Experts Think of the App?

While the Rejoyn app’s efficacy isn’t much higher than what the sham app achieved, mental health experts said there’s still value in using a treatment like this.

“When used in conjunction with clinician-lead care, whether that be medication management or therapy, I believe an app could be beneficial,” Hillary Ammon, PsyD, an assistant professor of psychiatry at the University of Pennsylvania’s School of Medicine, told Verywell. “After all, most people typically have their smartphones nearby throughout most of the day.”

Ammon said the daily tasks in Rejoyn could be beneficial for patients. “Some individuals with depression may struggle with routine and completing daily tasks,” she added. “If being prompted to complete tasks through the app and reminders on a cell phone, individuals may have some additional accountability that cannot be accomplished through weekly or monthly appointments.”

Thea Gallagher, PsyD, a clinical assistant professor at NYU Langone Health and a co-host of the “Mind in View” podcast, said patients can use the app in their own time—an added benefit if someone only meets with a therapist once a week.

Gallagher said it’s concerning that Rejoyn’s efficacy isn’t much better than the sham app, but the Emotional Faces Memory Task training, in general, has shown a reduction in symptoms of depression.

“If it doesn’t hurt to use an app, what’s the harm in trying it and seeing if it has some benefit for you?” she said.

Ammon added that for people who have tried multiple interventions and not seen good results, it’s worth trying the app “in addition to their current clinical care.”

Rejoyn is expected to be available later this year.

Read Next: Best Online Therapy That Accepts Insurance

What This Means for You

Rejoyn is a prescription mobile app that treats major depressive disorder alongside talk therapy and antidepressants.

Read the original article on Verywell Health.