Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Depressive Disorder, Major Clinical Trial

Official title:

Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05267873
• Other study ID #: 17538
• Secondary ID: IRB00017538
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14146
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Duloxetine, Vortioxetine
Medications for major depressive disorder

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Duke University, National Institute of Mental Health (NIMH), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores	Higher score indicates greater severity of major depressive disorder.	6 months
Primary	9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores	Higher score indicates greater severity of major depressive disorder.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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