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CompletedNCT02691520Updated Oct 28, 2024

Epidemiology of Treatment Resistant Depression in Taiwan

An observational study in Depressive Disorder, Treatment-Resistant, sponsored by Janssen Research & Development, LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Janssen Research & Development, LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8,356
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depressive Disorder, Treatment-Resistant

Keywords

  • Treatment Resistant Depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 8,356 is above the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults aged 18 and older are randomly sampled from the National Health Insurance Research Database (NHIRD).

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8,356 participants (actual)
Patient registry
No

Groups and cohorts

  • Taiwan Participants with Treatment Resistant Depression

    Taiwan participants with Depression will be followed up to 8 years for incidence and duration of treatment resistant depression.

06

What researchers measure

Primary outcomes

  1. Incidence Percentage of Participants with Treatment Resistant Depression

    The percentage of beneficiaries of Taiwan's health insurance plan who developed treatment resistant depression during 2005

    Time frame: Approximately 8 Years

  2. Prevalence Percentage of Participants with Treatment Resistant Depression

    Time frame: Approximately 8 Years

  3. Duration of an episode of Depression

    Time from onset of depression to cessation of depression visits and medications.

    Time frame: Approximately 8 Years

Secondary outcomes

  1. Healthcare costs

    Direct healthcare cost associated with depression treatment will be assessed.

    Time frame: Approximately 8 Years

  2. Number of Participants With Comorbidities

    Time frame: Approximately 8 Years

  3. Medications used by Participants with Treatment Resistant Depression

    Time frame: Approximately 8 Years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02691520
Lead sponsor
Janssen Research & Development, LLC
Collaborators
Elysia Group
Responsible party
Sponsor
First posted
Feb 25, 2016
Start date
Sep 29, 2015
Primary completion
Feb 18, 2016
Completion
Feb 18, 2016
Last update
Oct 28, 2024

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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