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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Depressive Disorder, Major trials