Major Depressive Disorder with Inadequate Response to Antidepressant
Research type
Research Study
Full title
A Prospective, Observational Study of Participants with Major Depressive Disorder who\nhave an Inadequate Response to an Antidepressant
IRAS ID
296609
Contact name
Andrea Cipriani
Contact email
Sponsor organisation
Janssen Pharmaceutical Companies
Duration of Study in the UK
2 years, 0 months, 9 days
Research summary
This is a multicenter, prospective, 2-year observational study (non-interventional), who aims to describe the standard of care (SoC) in adult (18-64 years) and elderly (65-74 years) with major depressive disorder (MDD). \n\nThe aim of the study is to understand the demographic and disease characteristics as well as the standard of care (including effectiveness and safety outcomes, the clinical and economic burden of disease) of MDD participants with an inadequate response to an antidepressant. The population for this study will approximate the population included in clinical studies, focusing on participants who have had an inadequate response to monotherapy antidepressant treatment. Data will be collected continuously from the electronic health record (EHR) starting at baseline (start of the adjunctive treatment or antidepressant medication switch) for 2 years and/or from regularly scheduled clinical outcome assessments (COAs) every 3-6 months.\n\nThere will be two methods of enrollment in this study: (a) direct enrollment of patients, or (b) entry\nfrom study 42847922MDD3009 upon completing the 1-year follow-up in that study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0144
Date of REC Opinion
21 Jun 2021
REC opinion
Further Information Favourable Opinion