NCT03373253

Treatment-Resistant Depression Cohort in Europe

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 830 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the participants socio-demographics and disease-related characteristics, long-term naturalistic treatment patterns and the clinical, social and economic outcomes of routine clinical practice in the treatment of participants with treatment-resistant depression (TRD) in a variety of European countries.

Detailed description

This TRD cohort study will collect critically important data from routine clinical practice in Europe which will further substantiate the understanding of TRD in European clinical practice, with the aim of improving guidance and informing the development of better treatment strategies for this medically important condition. All data recorded in the case report form (CRF) should be documented in participants' medical records, that will be the primary data source of each participant. Participants who meet the diagnostic criteria for Major Depressive Disorder (MDD) and the diagnostic criteria for TRD, and are initiating or planned to initiate a new antidepressive treatment regimen will participate in the study. The end of the entire study will be 6 months after enrollment of the last participant in the study.

Conditions

• Depressive Disorder, Treatment-Resistant

Timeline

• Start date: 2018-02-13
• Primary completion: 2020-01-24
• Completion: 2020-01-24
• First posted: 2017-12-14
• Last updated: 2025-04-27

Locations

98 sites across 7 countries: Belgium, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom