Study identification

PURI

https://redirect.ema.europa.eu/resource/107562

EU PAS number

EUPAS106685

Study ID

107562

Official title and acronym

DARWIN EU® Rates of occurrence of treatment-related intercurrent events in patients with major depressive disorder

DARWIN EU® study

Yes

Study countries

Germany
Netherlands
Spain
United Kingdom

Study description

What 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.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Johnmary Arinze

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol
English (693.82 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable