Epidemiology of Treatment Resistant Depression in the US: Analysis of Health Services Databases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200,000
- Primary Endpoint
- Incidence Rate of Treatment Resistant Depression
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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
- •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
Outcomes
Primary Outcomes
Incidence Rate of Treatment Resistant Depression
Time Frame: Up to 4 years
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.
Treatment Resistant Depression as a Proportion of Pharmacologically Treated Depression
Time Frame: Up to 4 years
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.
Incidence Rate of Treatment Resistant Depression by Age Group and Sex
Time Frame: Up to 4 years
TRD incidence will be stratified by age group and sex under each of the three definitions of failure of a medication regimen.
Incidence Rate of TRD as Separate Estimates for the Medicaid Population, the Medicare Population, and the Privately Insured Population
Time Frame: Up to 4 years
TRD incidence will be stratified by data population (database): Medicaid, Medicare, Privately insured.
Secondary Outcomes
- 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)