Depressive Disorder, Major
Conditions
Brief 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.
Interventions
DRUGDuloxetine, Vortioxetine
Medications for major depressive disorder
Sponsors
Johns Hopkins Bloomberg School of Public Health
Duke University
Patient-Centered Outcomes Research Institute
National Institute of Mental Health (NIMH)
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores | 6 months | Higher score indicates greater severity of major depressive disorder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency room visits or inpatient admissions with diagnosis of depression or suicidality | 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". |
| Emergency room visits or inpatient admissions for any reason | 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". |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Stuart, PhD
Johns Hopkins Bloomberg School of Public Health
PRINCIPAL_INVESTIGATORHwanhee Hong, PhD
Department of Biostatistics & Bioinformatics, Duke University
Outcome results
None listed