Skip to main content
OpenTrials
Completed

NCT Number: NCT05267873

Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine, Vortioxetine

Drug

Medications for major depressive disorder

Primary outcomes

  1. 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores

    Time frame: 6 months

    Higher score indicates greater severity of major depressive disorder.

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

    Time frame: 1 year

    Higher score indicates greater severity of major depressive disorder.

Secondary outcomes

  1. Emergency room visits or inpatient admissions with diagnosis of depression or suicidality

    Time frame: 6 months

    A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter with depression or suicidality International Classification of Diseases (ICD) codes, otherwise equals to "No".

  2. Emergency room visits or inpatient admissions with diagnosis of depression or suicidality

    Time frame: 1 year

    A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter with depression or suicidality International Classification of Diseases (ICD) codes, otherwise equals to "No".

  3. Emergency room visits or inpatient admissions for any reason

    Time frame: 6 months

    A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter after the prescription, otherwise equals to "No".

  4. Emergency room visits or inpatient admissions for any reason

    Time frame: 1 year

    A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter after the prescription, otherwise equals to "No".

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Duke University
  • National Institute of Mental Health (NIMH)
  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2024
First posted
Mar 4, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.