Treatment-Resistant Depression (54135419DEP4001)
Research type
Research Study
Full title
Treatment-Resistant Depression Cohort in Europe
IRAS ID
236320
Contact name
Allan Young
Contact email
Sponsor organisation
Janssen-Cilag Ltd.
Clinicaltrials.gov Identifier
n/A, N/A
Duration of Study in the UK
1 years, 9 months, 17 days
Research summary
This is an observational study that will be conducted in several countries within the European region. The purpose of the study is to collect information about treatments in people who suffer from depression. Major depressive disorder (MDD) is a common mood disorder, affecting approximately 15% of the general population, and is associated with significant morbidity and mortality, being a leading cause of disability and the psychiatric diagnosis most commonly associated with suicide.
For this purpose, the study is designed to document how the study doctors manages the mental state of participants and treatments the participants receive. Participation in the study will not change the prescription or intake of any medication the patients are receiving in their routine treatment.
Before any information is collected, participants will be asked to read and sign informed consent form.
The duration of participation in the study is approximately 12 months.
Male and Female patients aged 18 to 64 years will be eligible to participate in this study if they fulfil all the inclusion criteria. It is expected that approximately 96 centres in the region will be opened around the world in order to enrol 500 participants for evaluation.REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0031
Date of REC Opinion
14 Feb 2018
REC opinion
Further Information Favourable Opinion