CompletedNot Applicable

Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

United States9,586 participantsStarted 2015-01-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores

Timeframe: 6 months

9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores

Timeframe: 1 year

Trial details

NCT IDNCT05267873

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-31