Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Johns Hopkins Bloomberg School of Public Health

Status: Active, not recruiting

Conditions: Depressive Disorder, Major

Treatments: Drug: Duloxetine, Vortioxetine

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05267873

IRB00017538 (Other Identifier)

17538

Details and patient eligibility

About

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.

Enrollment: 14,146 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

14,146 participants in 6 patient groups

Duke Health System Electronic Health Record

Description:

Patients who received Duloxetine or Vortioxetine

Treatment:

Drug: Duloxetine, Vortioxetine

Johns Hopkins Health System Electronic Health Record

Description:

Patients who received Duloxetine or Vortioxetine

Treatment:

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 1 (NCT01153009)

Description:

Patients who received Duloxetine or Vortioxetine

Treatment:

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 2 (NCT01140906)

Description:

Patients who received Duloxetine or Vortioxetine

Treatment:

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 3 (NCT00672620)

Description:

Patients who received Duloxetine or Vortioxetine

Treatment:

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 4 (NCT00635219)

Description:

Patients who received Duloxetine or Vortioxetine

Treatment:

Drug: Duloxetine, Vortioxetine