FDA Approves First Digital Treatment for Major Depression

Meet Rejoyn: The first FDA approved digital app-based treatment program for major depression. Rejoyn is a the first ever prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct (add-on) treatment for patients 22 years and older who meet specified qualifications (see: FDA-Approved Indications). This exciting new MDD treatment option is coming soon! Per the manufacturer website, Rejoyn will be available sometime this summer 2024 for download on the App Store® or Google Play™.

Patient Eligibility Requirements:

-History of Major Depressive Disorder (MDD)

-At least 22 years old

-Currently taking antidepressant medication

-Proficient with written and spoken English

-Access to a smartphone

-Familiar with the use of mobile applications (apps)

Do I need a Prescription?

Yes, your healthcare provider will prescribe Rejoyn and send your prescription to a pharmacy that dispenses Rejoyn access codes. NOTE: not all pharmacies will have access, contact Rejoyn for more information (contact info below)

FDA-Approved Indications (1):

Rejoyn is FDA-approved as an adjunct treatment for Major Depressive Disorder (MDD) symptoms to be used with clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

Safety Information (1):

Rejoyn is not intended to be used as monotherapy, or as a standalone treatment. Rejoyn does not replace your current medication, including medication for treatment of MDD. You should continue your current treatment as directed by your healthcare provider.

Rejoyn cannot send alerts or warnings to your healthcare provider. If you feel that your depression symptoms are worsening or if you have feelings or thoughts of harming yourself or others, please contact your healthcare provider, dial 911, or go to the nearest emergency room immediately.

What makes Rejoyn different than other "therapy" applications?

Rejoyn is not a wellness app, but rather a 6-week prescription brain-training program that is designed to help improve how the brain processes emotions. In a clinical trial (the results of which I could not easily find), results showed that adding Rejoyn to an antidepressant resulted in:

• Reduced symptoms of depression

• No negative side effects

Rejoyn's therapeutic application shows potential for positive outcomes for patients with depression, as illustrated by clinical trial results (1). Most notably, Rejoyn's program is drug-free: there are no drug interactions, side effects, or direct health consequences associated with Rejoyn. Rejoyn is comparable to the reward of medication use, but without the repercussions. Now, this does not mean that Rejoyn's program is the cure-all for major depression. If it were, you would have heard about it by now.

Program Details:

Rejoyn's therapeutic program is a 6-week Rx-only therapeutic brain training course, or program, which is completed entirely through Rejoyn's smartphone application. Rejoyn's therapeutic process is made up of three parts: Therapeutic Lessons, Brain Exercises, and Personalized Reminders and Messaging. For more information about the length and contents of Rejoyn's therapeutic program, please see the link below.

Tech Qualifications:

Rejoyn is compatible with android and iphone users. Users must be proficient with written and spoken English, have access to a smartphone, and be familiar with the use of mobile applications (apps). An internet connection is required to download Rejoyn on your smartphone. Rejoyn is not currently compatible for use with computers or tablets.

For more Patient/Program Information: Click Here to Access Rejoyn's Official Website

Resources; 1) Rejoyn: first Rx digital therapeutic for MDD symptoms. Information for Healthcare Providers. Available online at https://www.rejoynhcp.com/

2)Aguilar, M. Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market. Stat: reporting from the frontiers of health and medicine. Available online at https://www.statnews.com/2024/04/01/otsuka-digital-therapy-depression-gains-fda-clearance/