Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Duloxetine, Vortioxetine

• Registration Number: NCT05267873
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2021-12-31
• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-04
• Status Verified: 2024-12
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9586

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duke Health System Electronic Health Record	Duloxetine, Vortioxetine	Patients who received Duloxetine or Vortioxetine
Randomized Controlled Trial 3 (NCT00672620)	Duloxetine, Vortioxetine	Patients who received Duloxetine or Vortioxetine
Johns Hopkins Health System Electronic Health Record	Duloxetine, Vortioxetine	Patients who received Duloxetine or Vortioxetine
Randomized Controlled Trial 1 (NCT01153009)	Duloxetine, Vortioxetine	Patients who received Duloxetine or Vortioxetine
Randomized Controlled Trial 2 (NCT01140906)	Duloxetine, Vortioxetine	Patients who received Duloxetine or Vortioxetine
Randomized Controlled Trial 4 (NCT00635219)	Duloxetine, Vortioxetine	Patients who received Duloxetine or Vortioxetine

Primary Outcome Measures

Name	Time	Method
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores	1 year	Higher score indicates greater severity of major depressive disorder.

Secondary Outcome Measures

Name	Time	Method
Emergency room visits or inpatient admissions with diagnosis of depression or suicidality	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".
Emergency room visits or inpatient admissions for any reason	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".

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States