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

Pfizer370,212 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

370,212

Conditions

Major Depression

Interventions

EscitalopramDRUG

Treatment for depression

ParoxetineDRUG

Treatment for depression

FluoxetineDRUG

Treatment for depression

Mirtazapine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 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\*)

Locations (1)

Pfizer

Seoul, South Korea

Outcomes

Primary Outcomes

Medication Possession Ratio (MPR) During First 180 Days of Treatment

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.

Time frame: From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)

Persistence During First 180 Days of Treatment

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.

Time frame: From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)

Percentage of Participants Who Discontinued Treatment in the First 90 Days From the Index Date

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.

Time frame: 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 Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])

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.

Data from ClinicalTrials.gov

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Treatment for depression

DuloxetineDRUG

Treatment for depression

SertralineDRUG

Treatment for depression

VenlafaxineDRUG

Treatment for depression

TianeptineDRUG

Treatment for depression

VortioxetineDRUG

Treatment for depression

DesvenlafaxineDRUG

Treatment for depression

BupropionDRUG

Treatment for depression

Time frame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 180 days of treatment (data collected and observed retrospectively)

Percentage of Participants Experiencing Recurrence During the Acute Treatment Phase

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.

Time frame: 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 Experiencing Recurrence After the Acute Treatment Phase

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.

Time frame: From day 91 to day 180 from the index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)

Percentage of Participants With Adverse Events (AE) Within Maintenance Phase of Treatment

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.

Time frame: 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)

Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment Phase

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.

Time frame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)

Average Daily Dosage at Index Date

Index date was the first prescription date of study treatment during the intake period.

Time frame: At index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)

Average Daily Dosage During the Acute Treatment Phase

Acute treatment phase was during the first 90-day period starting from the index date.

Time frame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)