Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

NCT05267873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9586

Last updated 2026-04-13

No results posted yet for this study

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 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.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Duloxetine, Vortioxetine

Medications for major depressive disorder

Sponsors & Collaborators

  • Duke University

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Elizabeth Stuart, PhD · Johns Hopkins Bloomberg School of Public Health

  • Hwanhee Hong, PhD · Department of Biostatistics & Bioinformatics, Duke University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2021-12-31
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267873 on ClinicalTrials.gov