Clinical trial NCT02691520: Epidemiology of Treatment Resistant Depression in Taiwan
Official title: Epidemiology of Treatment Resistant Depression in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Treatment-Resistant
Keywords: Treatment Resistant Depression
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Elysia Group
First posted: 2016-02-25
Enrollment: 8356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 18 and older are randomly sampled from the National Health Insurance Research Database (NHIRD).

Brief summary: The purpose of this study is to assess the epidemiology of Treatment Resistant Depression (TRD) in the nationally insured population in Taiwan including incidence, duration of clinical episodes, and prevalence by age and sex.

Detailed description: This is a retrospective study of approximately one million subjects randomly selected from an anonymized database National Health Insurance Research Database (NHIRD). Participants aged 18 years or older who have had neither a depression diagnosis nor a dispensing of an antidepressant medication in the last four months of 2004 will enter the study when they receive in 2005 a depression diagnosis and a dispensing of an antidepressant medication within 30 days of each other and will be followed up to 8 years or until they have 4 months with neither a depression diagnosis nor a dispensing of an antidepressant medication. Treatment Resistant Depression (TRD) Incidence, TRD prevalence by age and sex and duration of clinical episodes will be estimated.

Eligibility criteria: Inclusion Criteria:

* Participants who have been continuously enrolled in the insurance plan since January 1, 2004 (ignoring breaks of less than 30 days) and have not received an exclusion diagnosis and during the last 4 months of 2004, a) Have not received a diagnosis of depression and b) Have not received a dispensing of an AD medication
* Participants with a diagnosis of a depressive disorder including dysthymic disorder (International Classification of Diseases \[ICD\]-9 codes 296 depression-related, 300.4, 311) and Major Depressive Disorder (ICD-9 296.2, 296.3) will be followed through December 31, 2013

Exclusion Criteria:

- Participants who receive following diagnosis will be excluded, a) Mania, b) Schizophrenia (ICD-9 codes 295), c) Bipolar disorder (ICD-9 codes 296 bipolar-related), D) Dementia (ICD-9 codes 290 or 294); Note: Major depressive disorder (MDD) with psychotic behavior (ICD 296.24 for single episode, ICD 296.34 for recurrent episode) is not an exclusion

Primary outcomes:
measure: Incidence Percentage of Participants with Treatment Resistant Depression
timeFrame: Approximately 8 Years
measure: Prevalence Percentage of Participants with Treatment Resistant Depression
timeFrame: Approximately 8 Years
measure: Duration of an episode of Depression
timeFrame: Approximately 8 Years
Secondary outcomes:
measure: Healthcare costs
timeFrame: Approximately 8 Years
measure: Number of Participants With Comorbidities
timeFrame: Approximately 8 Years
measure: Medications used by Participants with Treatment Resistant Depression
timeFrame: Approximately 8 Years
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: