Trial · NCT04446039
Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
NCT04446039, Completed, Pfizer; results first posted 2024-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea. Trials, record NCT04446039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04446039
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
- NCT number
- NCT04446039
- Status
- Completed
- Enrollment
- 370,212 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Major Depression
- Interventions
- Escitalopram, Paroxetine, Fluoxetine, Mirtazapine, Duloxetine, Sertraline, Venlafaxine, Tianeptine, Vortioxetine, Desvenlafaxine, Bupropion
- First posted
- 2020-06-24
- Last updated
- 2024-12-09
- Results first posted
- 2024-12-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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. | Ratio | MEAN |
| PRIMARY | 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) | 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. | Days | MEAN |
| PRIMARY | 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) | 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. | Percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | Percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | Percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | Percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | Percentage of Participants | NUMBER |
| PRIMARY | 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) | FAS included participants who had newly initiated antidepressant therapies between 01-Jan-2018 to 30-Jun-2019, in the HIRA database. | Percentage of prescriptions | NUMBER |
| PRIMARY | Average Daily Dosage at Index Date | At index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively) | 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. | Milligrams per day | MEAN |
| PRIMARY | 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) | 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. | Milligrams per day | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Escitalopram | 0.47 | Standard Deviation 0.35 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Paroxetine | 0.49 | Standard Deviation 0.36 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Fluoxetine | 0.46 | Standard Deviation 0.34 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Sertraline | 0.48 | Standard Deviation 0.36 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Duloxetine | 0.47 | Standard Deviation 0.36 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Venlafaxine | 0.50 | Standard Deviation 0.36 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Desvenlafaxine | 0.53 | Standard Deviation 0.36 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Mirtazapine | 0.47 | Standard Deviation 0.36 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Tianeptine | 0.39 | Standard Deviation 0.33 | Ratio |
| Medication Possession Ratio (MPR) During First 180 Days of Treatment | Participants With Antidepressant Therapy | Vortioxetine | 0.50 | Standard Deviation 0.35 | Ratio |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Antidepressant Therapy | 370,212 | |
| Overall Study | COMPLETED | Participants With Antidepressant Therapy | 370,212 | |
| Overall Study | NOT COMPLETED | Participants With Antidepressant Therapy | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Antidepressant Therapy | 0 | 0 |
| Total, other adverse events | Participants With Antidepressant Therapy | 0 | 0 |
| Total, serious adverse events | Participants With Antidepressant Therapy | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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