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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Depressive Disorder, Treatment-Resistant

Study type: Observational

Funder types: Industry

Identifiers

NCT03109002

RRA-18629 (Other Identifier)

CR108308

Details and patient eligibility

About

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.

Enrollment: 200,000 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200,000 participants in 1 patient group

Cohort: Pharmacologically Treated Depression (PTD) Cases

Description:

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.