Clinical trial NCT03109002: An Epidemiology Study of Treatment Resistant Depression in the United States (US)
Official title: Epidemiology of Treatment Resistant Depression in the US: Analysis of Health Services Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Treatment-Resistant
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 200000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 will be assessed.

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.


Eligibility 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

Primary outcomes:
measure: Incidence Rate of Treatment Resistant Depression
timeFrame: Up to 4 years
measure: Treatment Resistant Depression as a Proportion of Pharmacologically Treated Depression
timeFrame: Up to 4 years
measure: Incidence Rate of Treatment Resistant Depression by Age Group and Sex
timeFrame: Up to 4 years
measure: Incidence Rate of TRD as Separate Estimates for the Medicaid Population, the Medicare Population, and the Privately Insured Population
timeFrame: Up to 4 years
Secondary outcomes:
measure: Incidence on TRD Based on Sensitivity Analysis
timeFrame: Up to 4 years
measure: Number of Participants With Selected Markers for Severity of Depression
timeFrame: Up to 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.