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

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

Official Title
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Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data

Conditions
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Major Depression

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Paroxetine
* Drug: Fluoxetine
* Drug: Mirtazapine
* Drug: Duloxetine
* Drug: Sertraline
* Drug: Venlafaxine
* Drug: Tianeptine
* Drug: Vortioxetine
* Drug: Desvenlafaxine
* Drug: Bupropion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Patients aged 18 years or older on the index date 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 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: Patients with a claim of diagnosis codes in Table 1 during the 12 month pre-index period Patients with a claim of prescription in Table 2 during the 12 month pre-index period Patient who had a claim as a beneficiary of Medical Aid program (Korean Medicaid program with free or minimum copay) Patients who are hospitalized at the index date Patients who are under hospice care (procedure codes WG*-WO*)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. Escitalopram Cohort<br> | Drug: Escitalopram<br>* Treatment for depression<br>|
| 2. Paroxetine Cohort<br> | Drug: Paroxetine<br>* Treatment for depression<br>|
| 3. Fluoxetine Cohort<br> | Drug: Fluoxetine<br>* Treatment for depression<br>|
| 4. Mirtazapine Cohort<br> | Drug: Mirtazapine<br>* Treatment for depression<br>|
| 5. Duloxetine Cohort<br> | Drug: Duloxetine<br>* Treatment for depression<br>|
| 6. Sertraline Cohort<br> | Drug: Sertraline<br>* Treatment for depression<br>|
| 7. Venlafaxine Cohort<br> | Drug: Venlafaxine<br>* Treatment for depression<br>|
| 8. Tianeptine Cohort<br> | Drug: Tianeptine<br>* Treatment for depression<br>|
| 9. Vortioxetine Cohort<br> | Drug: Vortioxetine<br>* Treatment for depression<br>|
| 10. Desvenlafaxine Cohort<br> | Drug: Desvenlafaxine<br>* Treatment for depression<br>|
| 11. Bupropion Cohort<br> | Drug: Bupropion<br>* Treatment for depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of antidepressants | Proportion out of total prescriptions in the first 90 days from the index date (acute treatment phase) by gender, age groups (20, 21-64, 65) | 90 days | 
| Dosage: Index date | Initial dosages at the index date | 90 days | 
| Dosage: Acute treatment phase | Average dosages during the first 90 days of treatment (acute treatment phase) | 90 days | 
| Persistence: Average length of treatment | Average length of treatment of each index drugs (allowing 14 day permissible gap) will be calculated. -Switching, combination, augmentation, discontinuation will terminate the persistent period | 6 months | 
| Discontinuation | Percentage of patients discontinued each index drug within first 90 days of index treatment | 90 days | 
| Adherence | For each index drug, adherence will be measured as percentage of drug possessed (measured by medication possession ratio) within 90 days of index treatment | 90 days | 
| Recurrence | Percentage of patients experiencing recurrence (as measured by inpatient episode, emergency room visit, or suicide attempt) within 6 months of treatment | 6 months | 
| Adverse outcomes | Percentage of adverse events (as measured by GI bleeding, fractures, falls, intracranial hemorrhage, suicide attempt, self-harm, myocardial infarction, epilepsy/seizures, stroke, hyponatremia) within 6 months of treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilization pattern in acute phase | Percentage of patients on monotherapy, combination therapy, augmentation therapy during 90 days of treatment | 90 days | 
| Drug utilization pattern in maintenance phase | Precentage of patients on monotherapy, combination therapy, augmentation therapy during 90-180 days of treatment | 90 days |