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Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

NCT ID: NCT04446039

Last Updated: 2024-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

370212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-04

Study Completion Date

2022-11-03

Brief Summary

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The primary purpose of this study is to investigate medication utilization pattern and risk of adverse outcomes among commonly used antidepressants by using nationwide claims database, in order to assess overall clinical benefit of antidepressant therapy in real-world practice.

Detailed Description

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While there are many antidepressants from which physicians can select based on efficacy and tolerability profile, evidence on effectiveness and safety outcomes of new antidepressants in real clinical practice among Korean MDD population is limited.

Hence, this study will explore the following primary, secondary objectives using national health insurance database :

1. Explore baseline characteristics and drug utilization patterns of 11 commonly used antidepressant therapy during 90 days of acute treatment phase
2. Explore drug utilization patterns such as therapy changes, medication compliance and recurrence relationship, and risk of adverse outcomes during maintenance phase
3. Choice of antidepressants and drug utilization patterns in patients with various comorbidities
4. The relationship of non-pharmacologic treatment and discontinuation, medication compliance
5. Choice of antidepressants by non-psychiatric specialty

Conditions

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Major Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1. Escitalopram Cohort

Escitalopram

Intervention Type DRUG

Treatment for depression

2. Paroxetine Cohort

Paroxetine

Intervention Type DRUG

Treatment for depression

3. Fluoxetine Cohort

Fluoxetine

Intervention Type DRUG

Treatment for depression

4. Mirtazapine Cohort

Mirtazapine

Intervention Type DRUG

Treatment for depression

5. Duloxetine Cohort

Duloxetine

Intervention Type DRUG

Treatment for depression

6. Sertraline Cohort

Sertraline

Intervention Type DRUG

Treatment for depression

7. Venlafaxine Cohort

Venlafaxine

Intervention Type DRUG

Treatment for depression

8. Tianeptine Cohort

Tianeptine

Intervention Type DRUG

Treatment for depression

9. Vortioxetine Cohort

Vortioxetine

Intervention Type DRUG

Treatment for depression

10. Desvenlafaxine Cohort

Desvenlafaxine

Intervention Type DRUG

Treatment for depression

11. Bupropion Cohort

Bupropion

Intervention Type DRUG

Treatment for depression

Interventions

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Escitalopram

Treatment for depression

Intervention Type DRUG

Paroxetine

Treatment for depression

Intervention Type DRUG

Fluoxetine

Treatment for depression

Intervention Type DRUG

Mirtazapine

Treatment for depression

Intervention Type DRUG

Duloxetine

Treatment for depression

Intervention Type DRUG

Sertraline

Treatment for depression

Intervention Type DRUG

Venlafaxine

Treatment for depression

Intervention Type DRUG

Tianeptine

Treatment for depression

Intervention Type DRUG

Vortioxetine

Treatment for depression

Intervention Type DRUG

Desvenlafaxine

Treatment for depression

Intervention Type DRUG

Bupropion

Treatment for depression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18 years or older on the index date
2. Patients who had at least one inpatient claim or two outpatient claims in the intake period with any of the following diagnosis codes F06.3 Organic mood \[affective\] disorders F32\* Depressive episode F33\* Recurrent depressive disorder F34.1 Neurotic depression F38.1 Other recurrent mood \[affective\] disorder F41.2 Mixed anxiety and depressive disorder
3. Patients prescribed any of the following antidepressant during intake period (from January 1, 2017 to June 30, 2018)

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

1. Patients with a claim of diagnosis codes in Table 1 during the 12 month pre-index period
2. Patients with a claim of prescription in Table 2 during the 12 month pre-index period
3. Patient who had a claim as a beneficiary of Medical Aid program (Korean Medicaid program with free or minimum copay)
4. Patients who are hospitalized at the index date
5. Patients who are under hospice care (procedure codes WG\*-WO\*)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Seoul, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B2061147

To obtain contact information for a study center near you, click here.

Other Identifiers

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CAR-BIG Study

Identifier Type: OTHER

Identifier Source: secondary_id

B2061147

Identifier Type: -

Identifier Source: org_study_id