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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04446039
Enrollment
370212
Registered
2020-06-24
Start date
2022-07-04
Completion date
2022-11-03
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

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

Interventions

DRUGEscitalopram

Treatment for depression

DRUGParoxetine

Treatment for depression

DRUGFluoxetine

Treatment for depression

DRUGMirtazapine

Treatment for depression

DRUGDuloxetine

Treatment for depression

DRUGSertraline

Treatment for depression

DRUGVenlafaxine

Treatment for depression

Treatment for depression

DRUGVortioxetine

Treatment for depression

DRUGDesvenlafaxine

Treatment for depression

DRUGBupropion

Treatment for depression

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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\*)

Design outcomes

Primary

MeasureTime frameDescription
Average Daily Dosage During the Acute Treatment PhaseFrom 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.
Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseFrom 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 DateAt 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.
Medication Possession Ratio (MPR) During First 180 Days of TreatmentFrom 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 TreatmentFrom 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 DateFrom 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 PhaseFrom 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 PhaseFrom 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 TreatmentFrom 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.

Other

MeasureTime frameDescription
Drug Utilization Pattern of Participants During 90-180 Days of TreatmentFrom 90 days to 180 days of treatment (data collected and observed retrospectively)The drug utilization pattern is presented according to the average treatment duration for each antidepressant during the maintenance treatment phases.
Percentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseFrom 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 received monotherapy, combination therapy and augmentation therapy during 90 days of treatment were assessed in this outcome measure. Acute treatment phase was during initial 90 days from the index date.

Countries

South Korea

Participant flow

Recruitment details

Participants who initiated antidepressants between 01-Jan-2018 to 30-Jun-2019 in Health Insurance Review and Assessment (HIRA) service database were observed in this retrospective study. Index date was first prescription date of study drugs during intake period (01-Jan-2018 to 31-Dec-2019). Acute phase was initial 90 days of treatment period and maintenance phase was from 91 to 180 days of treatment. Participants were followed up until 31-Dec-2020.

Pre-assignment details

A total of 370212 participants were included in the study.

Participants by arm

ArmCount
Participants With Antidepressant Therapy
Participants who initiated antidepressant therapy (escitalopram, paroxetine, fluoxetine, mirtazapine, duloxetine, sertraline, venlafaxine, tianeptine, vortioxetine, desvenlafaxine and bupropion) between 01-Jan-2018 to 30-Jun-2019 in the HIRA database were included and observed.
370,212
Total370,212

Baseline characteristics

CharacteristicParticipants With Antidepressant Therapy
Age, Continuous41.51 Years
STANDARD_DEVIATION 15.1
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
223994 Participants
Sex: Female, Male
Male
146218 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018, to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (MEAN)Dispersion
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateEscitalopram6.34 Milligrams per dayStandard Deviation 3.23
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateParoxetine13.01 Milligrams per dayStandard Deviation 5.5
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateFluoxetine16.30 Milligrams per dayStandard Deviation 8.55
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateSertraline38.75 Milligrams per dayStandard Deviation 19.56
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateDuloxetine34.80 Milligrams per dayStandard Deviation 12.91
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateVenlafaxine54.11 Milligrams per dayStandard Deviation 29.12
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateDesvenlafaxine51.91 Milligrams per dayStandard Deviation 11.32
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateMirtazapine8.71 Milligrams per dayStandard Deviation 5.56
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateTianeptine24.28 Milligrams per dayStandard Deviation 9.24
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateVortioxetine6.03 Milligrams per dayStandard Deviation 2.62
Participants With Antidepressant TherapyAverage Daily Dosage at Index DateBupropion152.97 Milligrams per dayStandard Deviation 53.43
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Overall Number of Participants Analyzed' signifies number of participants who were treated with monotherapy and 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (MEAN)Dispersion
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseEscitalopram7.94 Milligrams per dayStandard Deviation 4.13
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseParoxetine15.27 Milligrams per dayStandard Deviation 7.48
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseFluoxetine19.07 Milligrams per dayStandard Deviation 10.34
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseSertraline49.91 Milligrams per dayStandard Deviation 30.24
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseDuloxetine37.51 Milligrams per dayStandard Deviation 16.62
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseVenlafaxine69.12 Milligrams per dayStandard Deviation 39.98
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseDesvenlafaxine63.22 Milligrams per dayStandard Deviation 26.91
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseMirtazapine10.46 Milligrams per dayStandard Deviation 7.15
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseTianeptine21.71 Milligrams per dayStandard Deviation 9.85
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseVortioxetine8.26 Milligrams per dayStandard Deviation 3.95
Participants With Antidepressant TherapyAverage Daily Dosage During the Acute Treatment PhaseBupropion162.75 Milligrams per dayStandard Deviation 67.75
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (MEAN)Dispersion
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentEscitalopram0.47 RatioStandard Deviation 0.35
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentParoxetine0.49 RatioStandard Deviation 0.36
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentFluoxetine0.46 RatioStandard Deviation 0.34
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentSertraline0.48 RatioStandard Deviation 0.36
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentDuloxetine0.47 RatioStandard Deviation 0.36
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentVenlafaxine0.50 RatioStandard Deviation 0.36
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentDesvenlafaxine0.53 RatioStandard Deviation 0.36
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentMirtazapine0.47 RatioStandard Deviation 0.36
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentTianeptine0.39 RatioStandard Deviation 0.33
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentVortioxetine0.50 RatioStandard Deviation 0.35
Participants With Antidepressant TherapyMedication Possession Ratio (MPR) During First 180 Days of TreatmentBupropion0.45 RatioStandard Deviation 0.34
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseEscitalopram22.71 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseParoxetine23.58 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseFluoxetine23.74 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseSertraline22.91 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseDuloxetine25.48 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseVenlafaxine23.36 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseDesvenlafaxine23.81 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseMirtazapine24.64 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseTianeptine27.80 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseVortioxetine22 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence After the Acute Treatment PhaseBupropion21.85 Percentage of participants
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseEscitalopram16.42 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseParoxetine17.84 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseFluoxetine15.64 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseSertraline16.73 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseDuloxetine17.97 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseVenlafaxine17.73 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseDesvenlafaxine20.85 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseMirtazapine19.51 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseTianeptine16.34 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseVortioxetine17.62 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Experiencing Recurrence During the Acute Treatment PhaseBupropion16.13 Percentage of participants
Primary

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.

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Escitalopram30.31 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Paroxetine33.18 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Fluoxetine27.92 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Sertraline31.48 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Duloxetine30.73 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Venlafaxine33.39 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Desvenlafaxine37.20 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Mirtazapine30.32 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Tianeptine20.75 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Vortioxetine32.51 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])Bupropion27.16 Percentage of participants
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateEscitalopram14.82 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateParoxetine15.16 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateFluoxetine15.14 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateSertraline14.87 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateDuloxetine17.04 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateVenlafaxine14.04 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateDesvenlafaxine12.81 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateMirtazapine15.21 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateTianeptine22.27 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateVortioxetine12.94 Percentage of participants
Participants With Antidepressant TherapyPercentage of Participants Who Discontinued Treatment in the First 90 Days From the Index DateBupropion14.34 Percentage of participants
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentEscitalopram6.08 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentParoxetine6.44 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentFluoxetine4.29 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentSertraline6.09 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentDuloxetine9.59 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentVenlafaxine6.48 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentDesvenlafaxine7.50 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentMirtazapine10.36 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentTianeptine8.66 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentVortioxetine5.34 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants With Adverse Events (AE) Within Maintenance Phase of TreatmentBupropion4.68 Percentage of Participants
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseEscitalopram44.19 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseParoxetine10.1 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseFluoxetine12.15 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseSertraline8.89 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseDuloxetine2.3 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseVenlafaxine3.21 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseDesvenlafaxine1.75 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseMirtazapine4.1 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseTianeptine5.52 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseVortioxetine4.81 Percentage of prescriptions
Participants With Antidepressant TherapyPercentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment PhaseBupropion2.88 Percentage of prescriptions
Primary

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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (MEAN)Dispersion
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentEscitalopram76.11 DaysStandard Deviation 67.04
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentParoxetine79.83 DaysStandard Deviation 68.43
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentFluoxetine74.17 DaysStandard Deviation 65.32
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentSertraline77.34 DaysStandard Deviation 67.64
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentDuloxetine71.66 DaysStandard Deviation 67.64
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentVenlafaxine79.80 DaysStandard Deviation 68.79
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentDesvenlafaxine87.13 DaysStandard Deviation 68.81
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentMirtazapine73.12 DaysStandard Deviation 66.78
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentTianeptine54.48 DaysStandard Deviation 60.14
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentVortioxetine81.44 DaysStandard Deviation 66.5
Participants With Antidepressant TherapyPersistence During First 180 Days of TreatmentBupropion71.96 DaysStandard Deviation 63.82
Other Pre-specified

Drug Utilization Pattern of Participants During 90-180 Days of Treatment

The drug utilization pattern is presented according to the average treatment duration for each antidepressant during the maintenance treatment phases.

Time frame: From 90 days to 180 days of treatment (data collected and observed retrospectively)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

ArmMeasureGroupValue (MEAN)Dispersion
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentEscitalopram59.05 DaysStandard Deviation 27.21
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentParoxetine60.50 DaysStandard Deviation 26.73
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentFluoxetine56.07 DaysStandard Deviation 27.3
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentSertraline59.58 DaysStandard Deviation 26.95
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentDuloxetine59.25 DaysStandard Deviation 27.64
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentVenlafaxine61.17 DaysStandard Deviation 26.61
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentDesvenlafaxine63.65 DaysStandard Deviation 26.05
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentMirtazapine60.92 DaysStandard Deviation 27.17
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentTianeptine51.93 DaysStandard Deviation 29.53
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentVortioxetine60.91 DaysStandard Deviation 26.4
Participants With Antidepressant TherapyDrug Utilization Pattern of Participants During 90-180 Days of TreatmentBupropion57.34 DaysStandard Deviation 27.18
Other Pre-specified

Percentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment Phase

Percentage of participants who received monotherapy, combination therapy and augmentation therapy during 90 days of treatment were assessed in this outcome measure. Acute treatment phase was during initial 90 days 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)

Population: FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. One participant was evaluable for more than one row.

ArmMeasureGroupValue (NUMBER)
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Escitalopram78.92 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Escitalopram8.91 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: escitalopram14.01 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Paroxetine73.10 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Paroxetine10.91 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: paroxetine15.18 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Fluoxetine74.65 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Fluoxetine10.08 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: fluoxetine13.52 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Sertraline74.36 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Sertraline9.37 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: sertraline14.16 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Duloxetine68.91 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Duloxetine12.53 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: duloxetine14.31 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Venlafaxine67.58 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Venlafaxine13.11 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: venlafaxine14.69 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Desvenlafaxine68.56 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Desvenlafaxine13.48 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: desvenlafaxine17.86 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Mirtazapine71.22 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Mirtazapine13.01 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: mirtazapine15.92 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Tianeptine65.33 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Tianeptine14.13 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: tianeptine13.04 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Vortioxetine72.53 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Vortioxetine10.45 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: vortioxetine15.56 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseMonotherapy: Bupropion66.85 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseCombination: Bupropion17.12 Percentage of Participants
Participants With Antidepressant TherapyPercentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment PhaseAugmentation therapy: bupropion13.78 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026