CompletedNCT04446039Updated Dec 9, 2024Results posted

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

An observational study in Major Depression, sponsored by Pfizer. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Pfizer · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 370,212
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 :

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

Conditions studied

Major Depression

Browse trials for

Depressive Disorder, Major 2,741

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's enrollment of 370,212 is above the median of 140 across 357 observational studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Subjects who newly initiated antidepressant therapies between Jan 01, 2017 to Jun 30, 2018 in the National Health Insurance Service (NHIS) database

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

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*)

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 370,212 participants (actual)
Patient registry: No

Groups and cohorts

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

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
DrugTianeptine
Treatment for depression
DrugVortioxetine
Treatment for depression
DrugDesvenlafaxine
Treatment for depression
DrugBupropion
Treatment for depression

What researchers measure

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.
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)

Other outcomes

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)
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)

Results

Posted Dec 9, 2024

Participant flow

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.

Participant flow — Overall Study
Milestone	Participants With Antidepressant Therapy
Started	370212
Completed	370212
Not completed	0

Outcome measures

PrimaryMedication 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)
Reported as:: Mean · Ratio

Medication Possession Ratio (MPR) During First 180 Days of Treatment
Ratio	Participants With Antidepressant Therapy
Escitalopram	0.47 ± 0.35
Paroxetine	0.49 ± 0.36
Fluoxetine	0.46 ± 0.34
Sertraline	0.48 ± 0.36
Duloxetine	0.47 ± 0.36
Venlafaxine	0.50 ± 0.36
Desvenlafaxine	0.53 ± 0.36
Mirtazapine	0.47 ± 0.36
Tianeptine	0.39 ± 0.33
Vortioxetine	0.50 ± 0.35
Bupropion	0.45 ± 0.34

PrimaryPersistence 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)
Reported as:: Mean · Days

Persistence During First 180 Days of Treatment
Days	Participants With Antidepressant Therapy
Escitalopram	76.11 ± 67.04
Paroxetine	79.83 ± 68.43
Fluoxetine	74.17 ± 65.32
Sertraline	77.34 ± 67.64
Duloxetine	71.66 ± 67.64
Venlafaxine	79.80 ± 68.79
Desvenlafaxine	87.13 ± 68.81
Mirtazapine	73.12 ± 66.78
Tianeptine	54.48 ± 60.14
Vortioxetine	81.44 ± 66.50
Bupropion	71.96 ± 63.82

PrimaryPercentage 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)
Reported as:: Number · Percentage of participants

Percentage of Participants Who Discontinued Treatment in the First 90 Days From the Index Date
Percentage of participants	Participants With Antidepressant Therapy
Escitalopram	14.82
Paroxetine	15.16
Fluoxetine	15.14
Sertraline	14.87
Duloxetine	17.04
Venlafaxine	14.04
Desvenlafaxine	12.81
Mirtazapine	15.21
Tianeptine	22.27
Vortioxetine	12.94
Bupropion	14.34

PrimaryPercentage 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)
Reported as:: Number · Percentage of participants

Percentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])
Percentage of participants	Participants With Antidepressant Therapy
Escitalopram	30.31
Paroxetine	33.18
Fluoxetine	27.92
Sertraline	31.48
Duloxetine	30.73
Venlafaxine	33.39
Desvenlafaxine	37.20
Mirtazapine	30.32
Tianeptine	20.75
Vortioxetine	32.51
Bupropion	27.16

PrimaryPercentage 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)
Reported as:: Number · Percentage of participants

Percentage of Participants Experiencing Recurrence During the Acute Treatment Phase
Percentage of participants	Participants With Antidepressant Therapy
Escitalopram	16.42
Paroxetine	17.84
Fluoxetine	15.64
Sertraline	16.73
Duloxetine	17.97
Venlafaxine	17.73
Desvenlafaxine	20.85
Mirtazapine	19.51
Tianeptine	16.34
Vortioxetine	17.62
Bupropion	16.13

PrimaryPercentage 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)
Reported as:: Number · Percentage of participants

Percentage of Participants Experiencing Recurrence After the Acute Treatment Phase
Percentage of participants	Participants With Antidepressant Therapy
Escitalopram	22.71
Paroxetine	23.58
Fluoxetine	23.74
Sertraline	22.91
Duloxetine	25.48
Venlafaxine	23.36
Desvenlafaxine	23.81
Mirtazapine	24.64
Tianeptine	27.80
Vortioxetine	22
Bupropion	21.85

PrimaryPercentage 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)
Reported as:: Number · Percentage of Participants

Percentage of Participants With Adverse Events (AE) Within Maintenance Phase of Treatment
Percentage of Participants	Participants With Antidepressant Therapy
Escitalopram	6.08
Paroxetine	6.44
Fluoxetine	4.29
Sertraline	6.09
Duloxetine	9.59
Venlafaxine	6.48
Desvenlafaxine	7.50
Mirtazapine	10.36
Tianeptine	8.66
Vortioxetine	5.34
Bupropion	4.68

PrimaryPercentage 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)
Reported as:: Number · Percentage of prescriptions

Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment Phase
Percentage of prescriptions	Participants With Antidepressant Therapy
Escitalopram	44.19
Paroxetine	10.1
Fluoxetine	12.15
Sertraline	8.89
Duloxetine	2.3
Venlafaxine	3.21
Desvenlafaxine	1.75
Mirtazapine	4.1
Tianeptine	5.52
Vortioxetine	4.81
Bupropion	2.88

PrimaryAverage 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)
Reported as:: Mean · Milligrams per day

Average Daily Dosage at Index Date
Milligrams per day	Participants With Antidepressant Therapy
Escitalopram	6.34 ± 3.23
Paroxetine	13.01 ± 5.50
Fluoxetine	16.30 ± 8.55
Sertraline	38.75 ± 19.56
Duloxetine	34.80 ± 12.91
Venlafaxine	54.11 ± 29.12
Desvenlafaxine	51.91 ± 11.32
Mirtazapine	8.71 ± 5.56
Tianeptine	24.28 ± 9.24
Vortioxetine	6.03 ± 2.62
Bupropion	152.97 ± 53.43

PrimaryAverage 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)
Reported as:: Mean · Milligrams per day

Average Daily Dosage During the Acute Treatment Phase
Milligrams per day	Participants With Antidepressant Therapy
Escitalopram	7.94 ± 4.13
Paroxetine	15.27 ± 7.48
Fluoxetine	19.07 ± 10.34
Sertraline	49.91 ± 30.24
Duloxetine	37.51 ± 16.62
Venlafaxine	69.12 ± 39.98
Desvenlafaxine	63.22 ± 26.91
Mirtazapine	10.46 ± 7.15
Tianeptine	21.71 ± 9.85
Vortioxetine	8.26 ± 3.95
Bupropion	162.75 ± 67.75

Other pre-specifiedPercentage 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)
Reported as:: Number · Percentage of Participants

Percentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment Phase
Percentage of Participants	Participants With Antidepressant Therapy
Monotherapy: Escitalopram	78.92
Combination: Escitalopram	8.91
Augmentation therapy: escitalopram	14.01
Monotherapy: Paroxetine	73.10
Combination: Paroxetine	10.91
Augmentation therapy: paroxetine	15.18
Monotherapy: Fluoxetine	74.65
Combination: Fluoxetine	10.08
Augmentation therapy: fluoxetine	13.52
Monotherapy: Sertraline	74.36
Combination: Sertraline	9.37
Augmentation therapy: sertraline	14.16
Monotherapy: Duloxetine	68.91
Combination: Duloxetine	12.53
Augmentation therapy: duloxetine	14.31
Monotherapy: Venlafaxine	67.58
Combination: Venlafaxine	13.11
Augmentation therapy: venlafaxine	14.69
Monotherapy: Desvenlafaxine	68.56
Combination: Desvenlafaxine	13.48
Augmentation therapy: desvenlafaxine	17.86
Monotherapy: Mirtazapine	71.22
Combination: Mirtazapine	13.01
Augmentation therapy: mirtazapine	15.92
Monotherapy: Tianeptine	65.33
Combination: Tianeptine	14.13
Augmentation therapy: tianeptine	13.04
Monotherapy: Vortioxetine	72.53
Combination: Vortioxetine	10.45
Augmentation therapy: vortioxetine	15.56
Monotherapy: Bupropion	66.85
Combination: Bupropion	17.12
Augmentation therapy: bupropion	13.78

Other pre-specifiedDrug 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)
Reported as:: Mean · Days

Drug Utilization Pattern of Participants During 90-180 Days of Treatment
Days	Participants With Antidepressant Therapy
Escitalopram	59.05 ± 27.21
Paroxetine	60.50 ± 26.73
Fluoxetine	56.07 ± 27.30
Sertraline	59.58 ± 26.95
Duloxetine	59.25 ± 27.64
Venlafaxine	61.17 ± 26.61
Desvenlafaxine	63.65 ± 26.05
Mirtazapine	60.92 ± 27.17
Tianeptine	51.93 ± 29.53
Vortioxetine	60.91 ± 26.40
Bupropion	57.34 ± 27.18

Adverse events

Collected over Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Participants With Antidepressant Therapy	—	—	—

Baseline characteristics

Full analysis set (FAS) included participants who had newly initiated antidepressant therapies between 01-Jan-2018, to 30-Jun-2019, in the HIRA database.

Age, Continuous
Age, Continuous(Years)	Participants With Antidepressant Therapy
Mean	41.51 ± 15.10

Sex: Female, Male
Sex: Female, Male(Participants)	Participants With Antidepressant Therapy
Female	223994
Male	146218

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Participants With Antidepressant Therapy

Study locations

1 site

Pfizer
Seoul, Korea, Republic of

References and documents

Study documents

Study protocol · Feb 10, 2021
Statistical analysis plan · Dec 20, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04446039
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Jun 24, 2020
Start date: Jul 4, 2022
Primary completion: Nov 3, 2022
Completion: Nov 3, 2022
Results posted: Dec 9, 2024
Last update: Dec 9, 2024

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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