Epidemiology of Treatment Resistant Depression in Taiwan

Depressive Disorder, Treatment-Resistant Clinical Trial

Official title:

Epidemiology of Treatment Resistant Depression in Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691520
• Other study ID #: CR108117
• Secondary ID: NOPRODDEP4001
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2016
• Last updated: March 22, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Johnson & Johnson Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Health Research Institutes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8356
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pte Ltd	Elysia Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 8 Years	No
Primary	Prevalence Percentage of Participants with Treatment Resistant Depression		Approximately 8 Years	No
Primary	Duration of an episode of Depression	Time from onset of depression to cessation of depression visits and medications.	Approximately 8 Years	No
Secondary	Healthcare costs	Direct healthcare cost associated with depression treatment will be assessed.	Approximately 8 Years	No
Secondary	Number of Participants With Comorbidities		Approximately 8 Years	No
Secondary	Medications used by Participants with Treatment Resistant Depression		Approximately 8 Years	No