Status:
COMPLETED
Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Duke University
Patient-Centered Outcomes Research Institute
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Brief Summary
This work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. The met...
Eligibility Criteria
Inclusion
- Duke University Health System Electronic Health Record (EHR) System and Johns Hopkins Health System EHR System
- Inclusion criteria:
- All patients prescribed any Duloxetine or Vortioxetine in the health systems between 01/01/2015 - 12/31/2021.
- AND from patients with at least 1-year historical EHR data (burn-in period) without prescribing any of the two medications. During the burn-in period, patients should have at least one encounter in the system, and with no encounters during that time frame when they were prescribed Duloxetine or Vortioxetine.
- AND patients age 18-65 years old at baseline.
- Exclusion criteria:
- \- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.
- 4 randomized controlled trials (RCTs)
- Inclusion criteria:
- Male or female
- Age 18 years or older
- Major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) classification code 296.3x
- Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 26
- Clinical Global Impression - Severity (CGI-S) scale score ≥ 4
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
9586 Patients enrolled
Trial Details
Trial ID
NCT05267873
Start Date
January 1 2015
End Date
December 1 2024
Last Update
December 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205