Janssen VENTURA
Research type
Research Study
Full title
A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients with Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNRI
IRAS ID
327964
Contact name
Ramin Nilforooshan
Contact email
Sponsor organisation
Janssen Cilag Internation NV
Duration of Study in the UK
2 years, 7 months, 29 days
Research summary
Depression is a common and serious psychiatric disorder affecting approximately 280 million individuals worldwide (according to the WHO Fact Sheet 2021). An inadequate response to first-line SOC antidepressant treatment for MDD remains a significant problem resulting in persistent impairment and high utilization of health care resources. While switching antidepressants and using adjunctive treatments may improve response, almost 40% of patients remain symptomatic and fail to achieve full remission. Symptoms such as loss of interest/pleasure (anhedonia), insomnia, fatigue, have been reported to persist in patients treated with current antidepressants.
Our study is an observational, prospective, non-interventional, multinational, 12-month study to document the disease characteristics and the real-world standard of care use of available treatments in participants with MDD with anhedonia from a cohort of general MDD participants with an inadequate response to currently ongoing antidepressant treatment, inclusive of an SSRI or SNRI.
This study aims to describe the socio-demographic, disease-related and treatment-related characteristics, and the SOC treatment patterns of participants with MDD with anhedonia determined based on diagnostic information collected at study entry (see participant eligibility criterion 2) who have had an inadequate response to the current antidepressant treatment, inclusive of an SSRI or SNRI. This study may also serve as an external comparison arm to the Phase 3 data arising from MDD programs, should such an analysis be deemed feasible.REC name
West of Scotland REC 4
REC reference
23/WS/0109
Date of REC Opinion
18 Mar 2024
REC opinion
Further Information Favourable Opinion