Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Johns Hopkins Bloomberg School of Public Health9,586 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

9,586

Conditions

Depressive Disorder, Major

Interventions

Duloxetine, VortioxetineDRUG

Medications for major depressive disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Higher score indicates greater severity of major depressive disorder.

Time frame: 6 months

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

Higher score indicates greater severity of major depressive disorder.

Time frame: 1 year

Secondary Outcomes

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".

Time frame: 6 months

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

Time frame: 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".

Time frame: 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".

Time frame: 1 year

Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes