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FDA Authorizes New Digital Therapeutic App, CT-152, for Major Depression

Pharm'Up 2 min read

A new study published in the Journal of Affective Disorders has led to the FDA authorization of a digital therapeutic (DTx) for major depressive disorder (MDD). The product, a smartphone app named CT-152 (Rejoyn), has been shown to improve depression symptoms when used as an add-on to existing antidepressant therapy.

How the App Works

CT-152 is a prescription-based app that delivers a self-guided program combining two key therapeutic approaches:

  • Cognitive-Behavioral Therapy (CBT): This component teaches patients to identify and change negative thought patterns and behaviors.
  • Cognitive-Emotional Training: The app includes a unique “emotional faces memory task” (EFMT) that helps enhance brain connectivity in areas responsible for processing emotions.

The goal of this combination is to provide a non-pharmacologic intervention that can be easily accessed and used by patients remotely. The app also includes personalized text messages to provide support and encouragement.

Phase 3 Trial Results

A Phase 3 randomized, double-blind, sham-controlled trial evaluated the app’s safety and effectiveness in 386 adults with MDD who were already on stable antidepressant medication but were not experiencing a full reduction in their symptoms.

The study found a statistically significant improvement in depression symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), for the group using the CT-152 app compared to a control group using a “sham” app. No severe side effects were reported, and the app was well-received by both patients and providers, with many noting its convenience.

Implications for Healthcare

The approval of CT-152 offers a new, non-pharmacologic option for patients with MDD who are not getting a full response from their current medication. Since it avoids the side effects associated with additional drug therapy, it could be a valuable tool.

Healthcare professionals, including pharmacists and nurse practitioners, are encouraged to consider this as a treatment option and educate patients on how they can access it. While some insurance plans may not cover the therapeutic, patients can use their Health Savings Accounts (HSA) or Flexible Spending Accounts (FSA) for reimbursement.

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