Epidemiology of Treatment Resistant Depression in Taiwan

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Treatment-Resistant

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.

• Study Type: Observational
• Enrollment (Actual): 8356

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Prevalence Percentage of Participants with Treatment Resistant Depression		Approximately 8 Years
Duration of an episode of Depression	Time from onset of depression to cessation of depression visits and medications.	Approximately 8 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare costs	Direct healthcare cost associated with depression treatment will be assessed.	Approximately 8 Years
Number of Participants With Comorbidities		Approximately 8 Years
Medications used by Participants with Treatment Resistant Depression		Approximately 8 Years

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pte Ltd
• Collaborators: Elysia Group

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Estimate): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Treatment Resistant Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: CR108117; NOPRODDEP4001 (Other Identifier: Johnson & Johnson Pte Ltd)