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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome:

• 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 two alternative definitions. In one the time for a medication regimen to fail is limited to less than or equal to (<=) 3 months, corresponding to the medication never providing adequate relief. In the other, 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 two 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence on TRD Based on Sensitivity Analysis [ Time Frame: Up to 4 years ]
  Sensitivity analyses are intended to clarify how the results of the present study will compare to the results of other studies that may define as The maximum time for failure of a regimen is changed to: 60, 120, 150, 180, or 365 days, or is not limited; the requirement that a regimen include greater than or equal to (>=) 28 days' supply of the antidepressant medication and antipsychotic medication (if present) is changed to >= 42 days and 14 days supply; participants who get an excluded diagnosis are retroactively excluded from the study cohort; or the definition of an incident case adds a requirement for no depression diagnosis in the prior year.
• Number of Participants With Selected Markers for Severity of Depression [ Time Frame: Up to 4 years ]
  The following markers of severity will be tabulated during the PTD episodes and stratified according to whether the participant develops or does not develop TRD during the study period: Electro-convulsive therapy, hospitalization with a diagnosis of depression, receiving a diagnosis of suicidal thoughts, receiving a diagnosis of self-harm, emergency department visit with a diagnosis of injury, emergency department visit with a diagnosis of poisoning.

Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: April 6, 2017
Date Started: January 15, 2017
Date Completion: April 28, 2017
Last Updated: April 20, 2017
Last Verified: April 2017