Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05267873
Collaborator
Duke University (Other), Patient-Centered Outcomes Research Institute (Other)
14,146
1
120
117.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Duloxetine, Vortioxetine

Study Design

Study Type:
Observational
Anticipated Enrollment :
14146 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Duke Health System Electronic Health Record

Patients who received Duloxetine or Vortioxetine

Drug: Duloxetine, Vortioxetine

Johns Hopkins Health System Electronic Health Record

Patients who received Duloxetine or Vortioxetine

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 1 (NCT01153009)

Patients who received Duloxetine or Vortioxetine

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 2 (NCT01140906)

Patients who received Duloxetine or Vortioxetine

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 3 (NCT00672620)

Patients who received Duloxetine or Vortioxetine

Drug: Duloxetine, Vortioxetine

Randomized Controlled Trial 4 (NCT00635219)

Patients who received Duloxetine or Vortioxetine

Drug: Duloxetine, Vortioxetine

Outcome Measures

Primary Outcome Measures

  1. 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores [6 months]

    Higher score indicates greater severity of major depressive disorder.

  2. 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

  1. Emergency room visits or inpatient admissions with diagnosis of depression or suicidality [6 months]

    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".

  2. 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".

  3. Emergency room visits or inpatient admissions for any reason [6 months]

    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".

  4. 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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Bloomberg School of Public Health Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • Duke University
  • Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Elizabeth Stuart, PhD, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Hwanhee Hong, PhD, Department of Biostatistics & Bioinformatics, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT05267873
Other Study ID Numbers:
  • 17538
First Posted:
Mar 4, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022

Study Results

No Results Posted as of Apr 25, 2022