Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Study Overview
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Brief Summary
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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.

Official Title
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Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Duloxetine, Vortioxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Duke Health System Electronic Health Record<br>Patients who received Duloxetine or Vortioxetine | Drug: Duloxetine, Vortioxetine<br> <br> |
| Johns Hopkins Health System Electronic Health Record<br>Patients who received Duloxetine or Vortioxetine | Drug: Duloxetine, Vortioxetine<br> <br> |
| Randomized Controlled Trial 1 (NCT01153009)<br>Patients who received Duloxetine or Vortioxetine | Drug: Duloxetine, Vortioxetine<br> <br> |
| Randomized Controlled Trial 2 (NCT01140906)<br>Patients who received Duloxetine or Vortioxetine | Drug: Duloxetine, Vortioxetine<br> <br> |
| Randomized Controlled Trial 3 (NCT00672620)<br>Patients who received Duloxetine or Vortioxetine | Drug: Duloxetine, Vortioxetine<br> <br> |
| Randomized Controlled Trial 4 (NCT00635219)<br>Patients who received Duloxetine or Vortioxetine | Drug: Duloxetine, Vortioxetine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores | Higher score indicates greater severity of major depressive disorder. | 6 months | 
| 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores | Higher score indicates greater severity of major depressive disorder. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency room visits or inpatient admissions with diagnosis of depression or suicidality | 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. | 6 months | 
| Emergency room visits or inpatient admissions with diagnosis of depression or suicidality | 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. | 1 year | 
| Emergency room visits or inpatient admissions for any reason | 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. | 6 months | 
| Emergency room visits or inpatient admissions for any reason | 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. | 1 year |