An Epidemiology Study of Treatment Resistant Depression in the United States (US)

NCT03109002 | Completed

• 2 other identifiers: CR108308RRA-18629
• Study Type: observational
• Target: 200,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (4)

• Incidence Rate of Treatment Resistant Depression

  TRD will be defined as the failure of two medications, as marked by their replacement or supplementation with other medications using three alternative definitions. In one the time for a medication regimen to fail is limited to less than or equal to (\<=) 3 months and in the second the time for a medication regimen to fail is limited to \<= 6 months, both corresponding to the medication never providing adequate relief. In the third, the time for a medication regimen to fail will be limited to \<= 2 years, corresponding to the medication not providing permanent or very long lasting relief.

  Up to 4 years

• Treatment Resistant Depression as a Proportion of Pharmacologically Treated Depression

  An episode of PTD begins when a member of the study cohort receives a dispensing of an antidepressant (AD) medication and receives a diagnosis of depression between 180 days before that dispensing and 30 days after that dispensing.

  Up to 4 years

• Incidence Rate of Treatment Resistant Depression by Age Group and Sex

  TRD incidence will be stratified by age group and sex under each of the three definitions of failure of a medication regimen.

  Up to 4 years

• Incidence Rate of TRD as Separate Estimates for the Medicaid Population, the Medicare Population, and the Privately Insured Population

  TRD incidence will be stratified by data population (database): Medicaid, Medicare, Privately insured.

  Up to 4 years

Secondary Outcomes (2)

• Incidence on TRD Based on Sensitivity Analysis

  Up to 4 years

• Number of Participants With Selected Markers for Severity of Depression

  Up to 4 years

Study Arms (1)

Cohort: Pharmacologically Treated Depression (PTD) Cases

This study is based on anonymized health services data, study population include US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 as described by the Truven MarketScan Medicaid (MDCD), Truven MarketScan Medicare Supplemental (MCDR), and Truven MarketScan Commercial Claims and Encounters (CCAE) databases. Within each database, pharmacologically treated depression (PTD) cases incident during 2011 will be followed for up to 4 years to ascertain their TRD status and 1-year incidence rates for PTD and TRD. Participants will not receive any intervention as a part of this study. To assure they are incident rather than prevalent cases, study participants are required to have 1 year without a dispensing of an antidepressant medication before they can join the cohort.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 will be assessed.

You may qualify if:

• 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

You may not qualify if:

• \- Participants will be excluded when they receive diagnoses Schizophrenia, Bipolar disorder including mania or Dementia

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Related Publications (1)

• Fife D, Reps J, Cepeda MS, Stang P, Blacketer M, Singh J. Treatment resistant depression incidence estimates from studies of health insurance databases depend strongly on the details of the operating definition. Heliyon. 2018 Jul 26;4(7):e00707. doi: 10.1016/j.heliyon.2018.e00707. eCollection 2018 Jul. Erratum In: Heliyon. 2019 Mar 07;5(3):e01198. doi: 10.1016/j.heliyon.2019.e01198.

  PMID: 30094377 RESULT

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: January 15, 2017
• Primary Completion: May 18, 2017
• Study Completion: May 18, 2017
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share