Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Completed

Conditions studied: Depressive Disorder, Major

In brief

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 methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the Vivli trials resource) and non-experimental data from the Duke University Health System electronic health record and the Johns Hopkins Health System electronic health record systems.

Key facts

Study ID: NCT05267873
Run by: Johns Hopkins Bloomberg School of Public Health
People needed: 9586
Starts: 2015-01-01
Expected to finish: 2024-12-01
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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