External Control Study for the Seltorexant Phase 3 MDD program
Research type
Research Study
Full title
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
IRAS ID
293431
Contact name
Andrea Cipriani
Contact email
Sponsor organisation
Janssen Pharmaceutical Companies
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
This is a multicenter, prospective, 2-year observational study (non-interventional), in adults (18-64) and elderly (65-74) with major depressive disorder (MDD) who have had insufficient response to an antidepressant.
The goal of the study is to understand the demographic. disease characteristics and the standard of care (including efficacy and safety outcomes) of MDD patients with an inadequate response to an antidepressant.
Data will be collected continuously from the electronic health records (EHR) starting at baseline (start of the adjunctive treatment) for 2 years and/or regularly scheduled clinical outcome assessments every 3-6 months.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0063
Date of REC Opinion
27 Apr 2021
REC opinion
Further Information Favourable Opinion