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Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Johns Hopkins Bloomberg School of Public Health logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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