Completed

Epidemiology of Treatment Resistant Depression in the US: Analysis of Health Services Databases

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Mental Disorders+1

+ Depressive Disorder

+ Mood Disorders

Over 14 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2017
See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2017

Actual date on which the first participant was enrolled.

The purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group, with separate estimates for the Medicaid population, the Medicare population, and the privately insured population. Anonymized participants data will be used for the analysis.

Official TitleEpidemiology of Treatment Resistant Depression in the US: Analysis of Health Services Databases
NCT03109002
Principal SponsorJanssen Research & Development, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive DisorderMood DisordersDepressive Disorder, Treatment-Resistant

Criteria

Inclusion Criteria: * Have been in the database for the past year (ignoring breaks of \< 30 days) * Have not had, an excluded diagnosis or dispensing of an AD medication during the past year * Are aged 14 to 60 years (if in the CCAE or MCDC databases), or are aged greater than or equal to (\>=) 65 years (if in the MCDR database). Age is defined as age on Jan 1, 2011. The boundary at age 60 for the first two databases is intended to avoid loss to follow-up due to transfer to Medicare at age 65. The boundary at age 65 for the MCDR database reflects the fact that very few people described by that database are aged less than 65 Exclusion Criteria: \- Participants will be excluded when they receive diagnoses Schizophrenia, Bipolar disorder including mania or Dementia

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers