Status: Ongoing First registered on: 03/10/2023
Last updated on: 13/11/2023
1. Study identification
EU PAS Register NumberEUPAS106685
Official titleDARWIN EU® CC - Rates of occurrence of treatment-related intercurrent events in patients with major depressive disorder
Study title acronym
Study typeObservational study
Brief description of the studyWhat is the incidence of treatment-related intercurrent events common in clinical trials in patients with major depressive disorder? Study objectives, to examine the proportion of patients with newly diagnosed major depressive disorder who start treatment with antidepressants, NSRIs, SSRIs, or other anti-depressants, as well as those who switch or discontinue treatment at specific intervals 4, 6, 8, 12, and 24 weeks after treatment initiation, stratified by age, sex, and country - database during the study period 2013 - 2022, to estimate the duration of antidepressant, use in patients with newly diagnosed major depressive disorder who initiate treatment with antidepressants, NSRIs, SSRIs, or other antidepressants, stratified by age, sex, and country - database during the study period 2013 - 2022, to assess the proportions of patients with newly diagnosed major depressive disorder who initiate, switch, or discontinue treatment with psycholeptics, antipsychotics, anxiolytics, hypnotics, and sedatives at specific intervals 4, 6, 8, 12, and 24 weeks after starting antidepressant therapy, stratified by age, sex, and country - database during the study period 2013 - 2022.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU® CC
Centre locationRotterdam, Netherlands
Details of (Primary) lead investigator
Title Mr
Last name Arinze
First name Johnmary
Is this study being carried out with the collaboration of a research network?
Yes

Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

Erasmus MC, Netherlands
PSMAR, Spain
Countries in which this study is being conducted
International study

Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/07/202327/07/2023
Start date of data collection01/01/201301/01/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report30/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Arinze
First name Johnmary
Address line 1Dr Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Mrs 
Last name Schuemie 
First name Ilse 
Address line 1Dr Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
Top