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

NCT04446039 | Completed Results FDA Drug

• 2 other identifiers: B2061147CAR-BIG Study
• Study Type: observational
• Target: 370,212
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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 (2)

• Percentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During 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)

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

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

Study Arms (11)

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

Escitalopram DRUG

Treatment for depression

1. Escitalopram Cohort

Paroxetine DRUG

Treatment for depression

2. Paroxetine Cohort

Fluoxetine DRUG

Treatment for depression

3. Fluoxetine Cohort

Mirtazapine DRUG

Treatment for depression

4. Mirtazapine Cohort

Duloxetine DRUG

Treatment for depression

5. Duloxetine Cohort

Sertraline DRUG

Treatment for depression

6. Sertraline Cohort

Venlafaxine DRUG

Treatment for depression

7. Venlafaxine Cohort

Tianeptine DRUG

Treatment for depression

8. Tianeptine Cohort

Vortioxetine DRUG

Treatment for depression

9. Vortioxetine Cohort

Desvenlafaxine DRUG

Treatment for depression

10. Desvenlafaxine Cohort

Bupropion DRUG

Treatment for depression

11. Bupropion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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\*)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Paroxetine; Fluoxetine; Mirtazapine; Duloxetine Hydrochloride; Sertraline; Venlafaxine Hydrochloride; tianeptine; Vortioxetine; Desvenlafaxine Succinate; Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Thiophenes; Sulfur Compounds; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Piperazines; Phenols; Benzene Derivatives; Propiophenones; Ketones

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 4, 2022
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)