(#14) Efficacy of CT-152 for Major Depressive Disorder Using the Self-Reported 9-Item Patient Health Questionnaire in Participants With Baseline Anxiety Symptoms and/or Difficulty Sleeping

Abstract: Introduction: CT-152 is a prescription digital therapeutic adjunct to antidepressant medication for patients with major depressive disorder (MDD) that has shown benefit over sham on multiple clinician and participant-reported scales (NCT04770285). Patients with MDD frequently experience anxiety and sleeping-difficulties, which can exacerbate depressive episodes. These post hoc analyses assessed the efficacy of CT-152 versus sham in relieving depressive symptoms for participants with baseline comorbid anxiety symptoms and/or sleep-difficulties. 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. Subgroups of participants experiencing anxiety (General Anxiety Disorder-7 ?10; Hamilton Depression Rating Scale [HAMD]-Anxiety/Somatization ?7; HAMD-Anxiety ?3) or sleep symptoms (9-Item Patient Health Questionnaire [PHQ-9] line item for sleep and HAMD-sleep disturbance factor) were determined from baseline values at screening. Correlations were explored for PHQ-9 total score, line items, and responders from baseline to week 6 for participants in these subgroups. Results: CT-152 was favored over sham for participants with baseline anxiety and those with baseline sleeping-difficulties. For all subgroups, a higher number of responders was observed for CT-152 versus sham. Conclusions: CT-152 was favored over sham in PHQ-9 total scores for participants with baseline anxiety symptoms and/or sleeping-difficulties. These findings support the potential for broad therapeutic benefit of CT-152 for patients with MDD and common comorbid symptoms.Short Description: CT-152 is a prescription digital therapeutic adjunct to antidepressant medication for patients with major depressive disorder (MDD). These post hoc analyses assessed the efficacy of CT-152 versus sham in relieving depressive symptoms for participants with baseline comorbid anxiety symptoms and/or sleep-difficulties. CT-152 was favored over sham for participants with baseline anxiety and those with baseline sleeping-difficulties. For all subgroups, a higher number of responders was observed for CT-152 versus sham.Name of Sponsoring Organization(s): This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. Click Therapeutics, Inc. was a co-development collaborator.