Clinical trial NCT05267873: Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
Official title: Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Duke University
name: Patient-Centered Outcomes Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2022-03-04
Enrollment: 9586
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received Duloxetine or Vortioxetine

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.


Eligibility 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

Primary outcomes:
measure: 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
timeFrame: 6 months
measure: 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
timeFrame: 1 year
Secondary outcomes:
measure: Emergency room visits or inpatient admissions with diagnosis of depression or suicidality
timeFrame: 6 months
measure: Emergency room visits or inpatient admissions with diagnosis of depression or suicidality
timeFrame: 1 year
measure: Emergency room visits or inpatient admissions for any reason
timeFrame: 6 months
measure: Emergency room visits or inpatient admissions for any reason
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Elizabeth Stuart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biostatistics & Bioinformatics, Duke University
name: Hwanhee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References: