First Digital Treatment for Depression Gains FDA Approval; What Is 'Rejoyn' App?

The US Food and Drug Administration has approved using Rejoyn for treating major depressive disorder. This makes the app the first prescription digital treatment for depression.

Depression

Depression involves having a depressed mood as well as the loss of interest or pleasure in activities for prolonged periods. It is different from the usual mood changes and feelings that people experience in their everyday life. Depression can impact all aspects of a person's life, including relationships with friends, family, and the community. It could also lead to difficulties in school at work.

Anyone can be hit with depression. Individuals who have experienced grave losses, abuse, or other stressful events have a higher likelihood of developing depression. Women also have a higher likelihood compared to men.

Major depressive disorder is a common mental disorder across the US. In fact, roughly 18% of American adults say that they have depression and are receiving corresponding treatment. Based on research, around 30% of individuals who are on antidepressant medications are partial responders. This means that their depressive symptoms may persist alongside the medication use.

Rejoyn: The First Digital Treatment For Depression

Now, the FDA has approved the first prescription digital treatment for depression. The treatment is an app known as Rejoyn, which was developed by Otsuka Pharmaceutical and Click Therapeutics. The app is meant to be used with antidepressant medications. It can be used by individuals who are at least 22 years old and who have a major depressive disorder diagnosis.

According to Otsuka, the app makes use of a six-week program that mixes a new approach known as Emotional Faces Memory Task, which is a form of cognitive-emotional training and cognitive behavioral therapy lessons. As part of the tasks, participants have to identify and compare emotions shown on a series of faces.

Initial research reveals that such exercise could lead to the stimulation of the dorsolateral prefrontal cortex and amygdala, which are brain regions that are thought to play a role in depression. These exercises could also yield antidepressant effects.

Dr. Brian Iacoviella, the co-inventor of the Emotional Faces Memory Task and the scientific adviser at Click, shares that the app has a neuromodulatory mechanism that is meant to serve like brain physical therapy. It offers consistent and personalized brain-training exercises that could improve the connections in the regions of the brain that depression affects.

Because the medical device is classified as low- to medium-risk, it just has to prove that it is significantly equivalent to another device that is marketed in order to gain FDA approval.

Dr. John Kraus, the chief medical officer and executive vice president at Otsuka, shares that the app serves as an exciting and novel adjunctive treatment method for addressing symptoms of major depressive disorder that complements current care standards. Dr. Kraus adds that though traditional methods are usually effective, several have only partial responses to treatment.

The app will need a prescription for download and will hit the market in late 2024. Otsuka aims to make it both affordable and accessible, though price details were not revealed.

Preliminary Stages

However, according to Dr. John Torous, who is the director of Beth Israel Deaconess Medical Center's Division of Digital Psychiatry, who did not participate in Rejoyn's development, this cognitive-emotional training approach is not well-established. The doctor adds that research pertaining to it is still in its exploratory stage.

The FDA approval was given based on clinical trial results that involve 386 individuals who are 22 to 64 years of age. These individuals had a major depressive disorder diagnosis and were not responsive to antidepressant treatments. The participants were tasked to use either a sham app or Rejoyn app, with the former not having any cognitive behavior therapy or cognitive-emotional training.

Findings revealed that though Rejoyn users exhibited an improvement in their depressive symptoms from the baseline, the average change was not notably different compared to the changes seen with the other sham app. The trial also did not report any side effects.

Dr. Torous says that it is important to keep in mind that the trial did not show that the app yielded any benefits that are statistically significant. Rejoyn is also not meant to serve as a lone treatment for depression. He shares hopes of seeing more evidence coming in the future, noting that as a clinician psychiatrist, he wants to ensure that people use things that could help them become better.

Otsuka shares that it is looking into additional research areas, such as patient populations and other indications. However, they did not outline any other studies for follow-up.

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