First approved prescription digital therapy for major depression

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The U.S. Food and Drug Administration (FDA) has approved the first prescription digital treatment approved as an adjunctive therapy for major depressive disorder (MDD) symptoms.

The approval is for ReJoin, a six-week treatment program to enhance cognitive control of emotions as an adjunct to clinician-supervised outpatient treatment for adult MDD patients (age 22 and older) taking antidepressant medications.

The approval is based on the 13-week Mirai study of 386 participants, ages 22 to 64, diagnosed with MDD and taking antidepressants, and approved by Otsuka Pharmaceuticals and Click Therapeutics, Inc. who were randomly assigned to receive Rejoyn or a sham control app. Of the participants randomized to receive Rejoyn, those who received Rejoyn improved from baseline in the severity of their depressive symptoms.

Symptom improvement was consistently detected on both patient- and clinician-reported measures, including the Montgomery-Åsberg Depression Rating Scale, the Patient Health Questionnaire 9-item depression scale, and the Clinical Global Impression – Severity scale.

The rejoin group showed continued improvement at one month after completion of the six-week treatment program. No treatment-related adverse events were observed.

Dr. Brian Iacoviello, scientific advisor to Click Therapeutics, said in a statement, “ReJoin has a neuromodulatory mechanism designed to act like physical therapy for the brain by providing individualized and consistent brain training exercises designed to improve connectivity in brain regions affected by depression. It has neuromodulatory mechanisms designed to

“When stronger and more balanced connections are created, the areas of the brain that process and regulate emotions are better able to work together, and the symptoms of depression are improved.”

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