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NCT05267873

Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

NCT ID: NCT05267873

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9586 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Duke Health System Electronic Health Record

Patients who received Duloxetine or Vortioxetine

Duloxetine, Vortioxetine

Intervention Type DRUG

Medications for major depressive disorder

Johns Hopkins Health System Electronic Health Record

Patients who received Duloxetine or Vortioxetine

Duloxetine, Vortioxetine

Intervention Type DRUG

Medications for major depressive disorder

Randomized Controlled Trial 1 (NCT01153009)

Patients who received Duloxetine or Vortioxetine

Duloxetine, Vortioxetine

Intervention Type DRUG

Medications for major depressive disorder

Randomized Controlled Trial 2 (NCT01140906)

Patients who received Duloxetine or Vortioxetine

Duloxetine, Vortioxetine

Intervention Type DRUG

Medications for major depressive disorder

Randomized Controlled Trial 3 (NCT00672620)

Patients who received Duloxetine or Vortioxetine

Duloxetine, Vortioxetine

Intervention Type DRUG

Medications for major depressive disorder

Randomized Controlled Trial 4 (NCT00635219)

Patients who received Duloxetine or Vortioxetine

Duloxetine, Vortioxetine

Intervention Type DRUG

Medications for major depressive disorder

Interventions

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Duloxetine, Vortioxetine

Medications for major depressive disorder

Intervention Type DRUG

Eligibility Criteria

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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.

* 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

Exclusion Criteria

\- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.

4 randomized controlled trials (RCTs)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Stuart, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Hwanhee Hong, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biostatistics & Bioinformatics, Duke University

Locations

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Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00017538

Identifier Type: -

Identifier Source: org_study_id