A Prospective, Observational Standard of Care Study of Patients with Major Depressive Disorder Who Have Had an Inadequate Response to a Selective Serotonin Reuptake/Serotonin-Norepinephrine Reuptake Inhibitor Antidepressant as a Control Arm for the Safety Assessments in the Seltorexant Phase 3 Program

PI(s): Anne Marie Gebara, University of Pittsburgh Medical Center

Project Summary:This is a multicenter, prospective, 1-year observational (non-interventional) study of participants with Major Depressive Disorder (MDD) who have had insufficient response to an SSRI/SNRI (antidepressant) in adults (18-64 years) and elderly (65-74 years). The goal of the study is to identify participants who will participate in the ECA (external control arm) to serve as a safety comparator for the seltorexant Phase 3 clinical trial as well as to obtain data on the safety and effectiveness of products used under the SOC (standard of care) of patients who have failed to adequately respond to an SSRI or SNRI. The primary population will approximate the clinical study population with similar inclusion and exclusion criteria. For seltorexant, the primary population of interest is MDDIS (Major Depressive Disorder with insomnia symptoms). In one of the Phase 3 studies, patients with and without insomnia symptoms will be enrolled though the primary analysis will be in the MDDIS population. In the other Phase 3 studies, only MDDIS participants will be enrolled. Data will be collected continuously from the electronic health records (EHR) starting at baseline (start of the adjunctive treatment) for one year supplemented by regular clinical outcome assessments occurring every 3 months.

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