NCT05267873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,586

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

February 20, 2022

Last Update Submit

April 8, 2026

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (2)

  • 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores

    Higher score indicates greater severity of major depressive disorder.

    6 months

  • 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores

    Higher score indicates greater severity of major depressive disorder.

    1 year

Secondary Outcomes (4)

  • Emergency room visits or inpatient admissions with diagnosis of depression or suicidality

    6 months

  • Emergency room visits or inpatient admissions with diagnosis of depression or suicidality

    1 year

  • Emergency room visits or inpatient admissions for any reason

    6 months

  • Emergency room visits or inpatient admissions for any reason

    1 year

Study Arms (6)

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

Interventions

Duloxetine, VortioxetineDRUG

Medications for major depressive disorder

Duke Health System Electronic Health RecordJohns Hopkins Health System Electronic Health RecordRandomized Controlled Trial 1 (NCT01153009)Randomized Controlled Trial 2 (NCT01140906)Randomized Controlled Trial 3 (NCT00672620)Randomized Controlled Trial 4 (NCT00635219)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received Duloxetine or Vortioxetine

You may qualify if:

  • 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.

You may not qualify if:

  • \- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.
  • randomized controlled trials (RCTs)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (6)

  • Hua K, Wojdyla D, Carnicelli A, Granger C, Wang X, Hong H. Network Meta-Analysis With Individual Participant-Level Data of Time-to-Event Outcomes Using Cox Regression. Stat Med. 2025 Feb 28;44(5):e70027. doi: 10.1002/sim.70027.

    PMID: 39964207RESULT

  • Hua K, Wang X, Hong H. Network Meta-Analysis of Time-to-Event Endpoints With Individual Participant Data Using Restricted Mean Survival Time Regression. Biom J. 2025 Feb;67(1):e70037. doi: 10.1002/bimj.70037.

    PMID: 39967285RESULT

  • Brantner CL, Nguyen TQ, Parikh H, Zhao C, Hong H, Stuart EA. Precision Mental Health: Predicting Heterogeneous Treatment Effects for Depression through Data Integration. J R Stat Soc Ser C Appl Stat. 2025 Dec 12:10.1093/jrsssc/qlaf068. doi: 10.1093/jrsssc/qlaf068. Online ahead of print.

    PMID: 41496761RESULT

  • Brantner CL, Nguyen TQ, Tang T, Zhao C, Hong H, Stuart EA. Comparison of methods that combine multiple randomized trials to estimate heterogeneous treatment effects. Stat Med. 2024 Mar 30;43(7):1291-1314. doi: 10.1002/sim.9955. Epub 2024 Jan 25.

    PMID: 38273647RESULT

  • Brantner CL, Yu W, Zhao C, Jeon K, Ringlein GV, Wang Q, Lemoto E, Nguyen TQ, Gagliardi JP, Zandi PP, Goldstein BA, Stuart EA, Hong H. The challenges of integrating diverse data sources: A case study in major depression. Health Serv Outcomes Res Methodol. 2024 Oct 23:10.1007/s10742-025-00363-8. doi: 10.1007/s10742-025-00363-8. Online ahead of print.

    PMID: 41669555RESULT

  • Brantner CL, Chang TH, Nguyen TQ, Hong H, Stefano LD, Stuart EA. Methods for Integrating Trials and Non-experimental Data to Examine Treatment Effect Heterogeneity. Stat Sci. 2023 Nov;38(4):640-654. doi: 10.1214/23-sts890. Epub 2023 Nov 6.

    PMID: 38638306RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine HydrochlorideVortioxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Elizabeth Stuart, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • Hwanhee Hong, PhD

    Department of Biostatistics & Bioinformatics, Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 4, 2022

Study Start

January 1, 2015

Primary Completion

December 31, 2021

Study Completion

December 1, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)