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

Completed

Conditions: Major Depression

Interventions: Drug: Desvenlafaxine
Drug: Escitalopram
Drug: Paroxetine
Drug: Fluoxetine
Drug: Mirtazapine
Drug: Duloxetine
Drug: Sertraline
Drug: Venlafaxine
Drug: Tianeptine
Drug: Vortioxetine
Drug: Bupropion

Registration Number: NCT04446039

Lead Sponsor: Pfizer

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 370212

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
10. Desvenlafaxine Cohort	Desvenlafaxine	-
1. Escitalopram Cohort	Escitalopram	-
2. Paroxetine Cohort	Paroxetine	-
3. Fluoxetine Cohort	Fluoxetine	-
4. Mirtazapine Cohort	Mirtazapine	-
5. Duloxetine Cohort	Duloxetine	-
6. Sertraline Cohort	Sertraline	-
7. Venlafaxine Cohort	Venlafaxine	-
8. Tianeptine Cohort	Tianeptine	-
9. Vortioxetine Cohort	Vortioxetine	-
11. Bupropion Cohort	Bupropion	-

Primary Outcome Measures

Name	Time	Method
Medication Possession Ratio (MPR) During First 180 Days of Treatment	From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)	MPR= Days of medication possession from the prescriptions filled in the 180 days divided by (180 days plus + extra days of drug supply from the last prescription fill during the 180 days). MPR by each index drug including escitalopram, paroxetine, fluoxetine, mirtazapine, duloxetine, sertraline, venlafaxine, tianeptine, vortioxetine, desvenlafaxine and bupropion is reported in this outcome measure. Index date was first prescription date of study drugs during intake period.
Persistence During First 180 Days of Treatment	From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)	Persistence was defined as the average length of treatment on the index drugs (escitalopram, paroxetine, fluoxetine, mirtazapine, duloxetine, sertraline, venlafaxine, tianeptine, vortioxetine, desvenlafaxine and bupropion), allowing 14-day permissible gap. Index date was first prescription date of study drugs during intake period.
Percentage of Participants Who Discontinued Treatment in the First 90 Days From the Index Date	From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)	Percentage of participants who discontinued the treatment in first 90 days from the index date is reported in this outcome measure. Index date was the first prescription date of study treatment during the intake period.
Percentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])	From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 180 days of treatment (data collected and observed retrospectively)	Adherence was defined when MPR \>= 75%. MPR = (Days of medication possession from the prescriptions filled in the 180 days) / (180 days + extra days of drug supply from the last prescription fill during the 180 days. Index date was the first prescription date of study drugs during the intake period.
Percentage of Participants Experiencing Recurrence During the Acute Treatment Phase	From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)	Recurrence during the acute treatment phase was defined as either one of the following: 1) Inpatient episode with a diagnosis code. 2) Inpatient episodes via the department of psychiatry or emergency medicine. 3) Inpatient episode via nursing hospital. 4) Emergency room visit with a diagnosis code. 5) Suicide attempt. Acute phase considered as the first 90-day period starting from the index date. Index date was the first prescription date of study treatment during the intake period. Diagnosis codes used for inclusion were: F06.3-Organic mood(affective) disorders, F32\- Depressive episode, F33\- Recurrent depressive disorder, F34.1- Neurotic depression, F38.1- Other recurrent mood(affective) disorders, F41.2- Mixed anxiety and depressive disorder.
Percentage of Participants Experiencing Recurrence After the Acute Treatment Phase	From day 91 to day 180 from the index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)	Recurrence was defined as either one of the following: 1) Inpatient episode with a diagnosis code. 2) Inpatient episodes via the department of psychiatry or emergency medicine. 3) Inpatient episode via nursing hospital. 4) Emergency room visit with a diagnosis code. 5) Suicide attempt; antidepressant prescription after 30 days of drug holiday. Acute phase considered as the first 90-day period starting from the index date. Index date was the first prescription date of study treatment during the intake period.
Percentage of Participants With Adverse Events (AE) Within Maintenance Phase of Treatment	From 91 up to 180 days of treatment from index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)	An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. Maintenance phase was during the second 90-day period (91 to 180 days) starting from the index date. Index date was the first prescription date of study treatment during the intake period. Index date was the first prescription date of study treatment during the intake period.
Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment Phase	From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)	Percentage of prescriptions for commonly used antidepressants in acute treatment phase were assessed. Acute treatment phase was during the first 90-day period starting from the index date. Index date was the first prescription date of study treatment during the intake period.
Average Daily Dosage at Index Date	At index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)	Index date was the first prescription date of study treatment during the intake period.
Average Daily Dosage During the Acute Treatment Phase	From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)	Acute treatment phase was during the first 90-day period starting from the index date.