A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the...

Digital therapeutics (DTx) are a new treatment class for major depressive disorder (MDD). This study evaluated the effectiveness and safety of a novel DTx, CT-152 (Rejoyn™), for MDD adjunctive to antidepressant medication monotherapy.

Adults aged 22-64 years with MDD having an inadequate response to current antidepressant medication monotherapy were enrolled in a phase 3 multicenter, randomized, blinded, sham-controlled, remote trial with a 6-week intervention and 4-week extension. Delivered via smartphone apps, the CT-152 group received a cognitive-emotional and behavioral therapeutic intervention; the control group received a sham app with a working memory task. Both groups received supportive text messages and continued current antidepressant medication. The primary outcome was Montgomery-Åsberg Depression Rating Scale (MADRS) score change from baseline to week 6. Treatment-emergent adverse events (TEAEs) were assessed.

Overall, 386 participants were randomly assigned (CT-152, n = 194; sham, n = 192). In the primary efficacy analysis of participants with ≥ 1 treatment session and ≥ 1 MADRS assessment post-baseline (n = 354), MADRS score changed -9.03 in the CT-152 group and - 7.25 in the sham (difference, - 1.78; P = 0.0568). These results were consistent with data from additional patient and clinician scales. In a supportive analysis of the intent-to-treat sample (N = 386), the between-group difference in 6-week MADRS change from baseline was -2.12 (P = 0.0211), favoring CT-152. No TEAEs or discontinuations were considered related to CT-152, and no deaths occurred.

CT-152 resulted in depression symptom improvement and a favorable safety profile. Based on these data, CT-152 became the first FDA-authorized prescription DTx for the adjunctive treatment of MDD.