(#15) Responders and Participant-Reported Depressive Symptom Clusters That may Benefit From CT-152 Therapy for Major Depressive Disorder

Abstract: Introduction: CT-152 is a prescription digital therapeutic adjunct to antidepressant medication for patients with major depressive disorder (MDD). In the Mirai trial (NCT04770285), CT-152 showed benefit over sham on multiple clinician and participant-reported scales. This post hoc analysis assessed the efficacy of CT-152 through the Patient Health Questionnaire (PHQ)-9 and Generalized Anxiety Disorder (GAD)-7. 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 for clinical outcomes for the participant-reported PHQ-9 and GAD-7 total scores; symptom cluster short forms PHQ-2/4/8; PHQ-9 and GAD-7 line items; and responders from baseline to week 6. Results: Change from baseline favored CT-152 over sham overall and for 5/9 PHQ-9 and 1/7 GAD-7 line items. Short form symptom cluster total scores showed similar trends. CT-152 had more responders versus sham; the estimated number-needed-to-treat (NNT) was 5 (full response; ?50% improvement from baseline) or 9 (meaningful within-patient change response; ?6-point reduction in PHQ-9 total score); for every 100 patients treated, 11ñ20 additional patients would benefit. Conclusions: CT-152 was favored over sham for the PHQ-9 and GAD-7, associated line items, and short forms, and had a greater number of responders and lower NNT. These results support the potential of CT-152 for broad therapeutic benefit for patients with MDD and other comorbid symptomology.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 efficacy of CT-152 through the Patient Health Questionnaire (PHQ)-9 and Generalized Anxiety Disorder (GAD)-7 versus sham. CT-152 was favored for PHQ-9 and GAD-7 scores, and had more responders and a lower number-needed-to-treat. This supports the potential for broad therapeutic benefit of CT-152 for patients with MDD and other comorbid symptomology.Name of Sponsoring Organization(s): This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. Click Therapeutics, Inc. was a co-development collaborator.