(#16) Symptoms of Major Depressive Disorder That Potentially Benefit From the Digital Therapeutic CT-152

Abstract: Introduction: CT-152 is a prescription digital therapeutic adjunct to antidepressant medication for patients with major depressive disorder (MDD). This post hoc analysis of the Mirai trial (NCT04770285) assessed the role of baseline participant characteristics on clinical outcomes and the clinical efficacy of CT-152 through Montgomery-≈sberg Depression Rating Scale (MADRS) symptom clusters and line items. Methods: In Mirai (6-week intervention/4-week extension periods), adults (22ñ64 years; Nf386) with MDD and inadequate response to current antidepressant medication were randomly assigned to CT-152 (n=194) or sham (n=192) smartphone apps. CT-152 included the Emotional Faces Memory Task and cognitive behavioral therapy-based lessons; sham included a time/attention/expectation-matched memory task. Correlations were explored between clinical outcomes and baseline demographic characteristics and psychiatric evaluation scores. Clinical efficacy was assessed as change in MADRS symptom clusters and line items at week 6 compared with sham. Results: Baseline psychiatric line items from clinical scales showed small correlations with MADRS change from baseline to week 6. All 7 symptom clusters were numerically improved in the CT-152 group compared with the sham group at week 6. Compared with the sham group, the CT-152 group showed numerical improvement in 9/10 MADRS line items. Conclusions: No baseline characteristics showed a strong correlation with week 6 MADRS outcomes in the CT-152 group, and there was no singular symptom or type of participant that benefited most. CT-152 showed numerical improvements versus sham in core features of MDD. These findings support the potential for broad therapeutic efficacy of CT-152 across different patient types and symptom profiles.Short Description: CT-152 is a prescription digital therapeutic adjunct to antidepressant medication for patients with major depressive disorder (MDD). This post hoc analysis assessed the role of baseline participant characteristics on clinical outcomes and the clinical efficacy of CT-152 through the Montgomery-≈sberg Depression Rating Scale. No baseline characteristics were strongly correlated with clinical outcomes, and CT-152 showed numerical improvements versus sham in core features of MDD. This supports the potential for broad therapeutic efficacy of CT-152.Name of Sponsoring Organization(s): This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. Click Therapeutics, Inc. was a co-development collaborator.