FDA approves first digital treatment for depression

ConsumerAffairs

The smartphone app is designed to work alongside other depression treatments

The Food and Drug Administration (FDA) has approved a new smartphone app, Rejoyn, for the treatment of depression

The app was created by Otsuka Pharmaceutical Co. and Click Therapeutics, and it offers users a six-week treatment program for major depressive disorder. This is the first prescription digital therapeutic authorized for depression treatment. 

“Rejoyn represents a novel and exciting adjunctive treatment option to major depressive disorder (MDD) symptoms that complement the current standard of care,” said Dr. John Kraud, executive vice president and chief medical officer at Otsuka. “While traditional approaches are often effective, many are left with only a partial response to treatment.” 

The science behind the app

Prior to receiving FDA approval, Rejoyn was tested during a 13-week clinical trial. Nearly 400 participants between the ages of 22 and 64 were involved in the study, and all of them were taking antidepressants throughout the trial. 

Over the course of the trial, participants either used the Rejoyn app or a control app. Then, the researchers analyzed their mental health outcomes using three scales: the Montgomery-Asberg Depression Rating Scale, the Patient Health Questionnaire nine-item depression scale, and the Clinical Global Impression – Severity scale. 

Ultimately, the participants using Rejoyn showed consistent improvements after using the app over the course of six weeks. Their depression symptoms had improved from baseline, and there were no adverse effects noted at the end of the trial. 

“Rejoyn has a neuromodulatory mechanism designed to act 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,” said Brian Iacovellio, PhD, scientific advisor at Click Therapeutics. “When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve.” 

How does it work? 

Exercises in the Rejoyn app use a combination of cognitive behavioral therapy (CBT) and emotional face memory tasks (EFMT). 

The CBT lessons focus on three main principles: 

  • Cognitive restructuring: reframing damaging thoughts

  • Behavioral activation: increasing behaviors that are good for mental health 

  • Emotional regulation: the ability to regulate how intensely an emotion is felt or the influence the emotion has 

Similarly, the EFMTs work to give users greater control over the processing of emotions and emotional information. 

A complement to depression treatment

It’s important to note that Rejoyn is designed to work in conjunction with other traditional depression treatments – medication and/or mental health counseling. 

The app will begin to be available on the App Store and Google Play store later this year, and users will need a prescription prior to downloading. More information on the cost of Rejoyn will be available in the coming months. 

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