A Prescription Digital Therapeutic, CT-152, for Treating Major Depressive Disorder: Effectiveness and Safety Results of the MIRAI Randomized Controlled Trial
Introduction: Digital therapeutics (DTx) are a new treatment class for major depressive disorder (MDD). CT-152 is a novel prescription DTx recently cleared by the FDA. This randomized controlled trial evaluated the effectiveness and safety CT-152 as an adjunct to antidepressant treatment (ADT) monotherapy (NCT04770285).
Methods: Adults aged 22–64 years with MDD having an inadequate response to current ADT were enrolled in a phase 3 multicenter, randomized, masked, sham-controlled, virtual trial with a 6-week intervention period and 4-week extension. Delivered via smartphone apps, the CT-152 group received a cognitive-emotional and behavioral therapeutic intervention whereas the control group received a sham app with a working memory task; all received supportive text messages and continued their current ADT. The primary outcome was Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from baseline to week 6. Treatment-emergent adverse events (TEAEs) were assessed.
Results: Of 1034 adults screened, 386 were randomized to CT-152 (n=194) or 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=.0568). These MADRS results were consistent with data from additional patient and clinician scales. In a supportive analysis of the intent-to-treat sample (Nf386), the between-group difference in 6-week MADRS score change from baseline was −2.12 (P=.0211), favoring CT-152. No TEAEs or discontinuations were considered related to CT-152, and no deaths occurred.
Conclusions: CT-152 resulted in depression symptom improvement with a demonstrated safety profile.
