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

NCT04446039

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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*)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Major DepressionEffect of Antidepressants on White Matter Structure
NCT01492621
  1. Montreal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major DepressionNon-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
NCT04446039
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
Official Title Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Major Depression
Intervention
  • Drug: Escitalopram
    Treatment for depression
  • Drug: Paroxetine
    Treatment for depression
  • Drug: Fluoxetine
    Treatment for depression
  • Drug: Mirtazapine
    Treatment for depression
  • Drug: Duloxetine
    Treatment for depression
  • Drug: Sertraline
    Treatment for depression
  • Drug: Venlafaxine
    Treatment for depression
  • Drug: Tianeptine
    Treatment for depression
  • Drug: Vortioxetine
    Treatment for depression
  • Drug: Desvenlafaxine
    Treatment for depression
  • Drug: Bupropion
    Treatment for depression
Study Groups/Cohorts
  • 1. Escitalopram Cohort
    Intervention: Drug: Escitalopram
  • 2. Paroxetine Cohort
    Intervention: Drug: Paroxetine
  • 3. Fluoxetine Cohort
    Intervention: Drug: Fluoxetine
  • 4. Mirtazapine Cohort
    Intervention: Drug: Mirtazapine
  • 5. Duloxetine Cohort
    Intervention: Drug: Duloxetine
  • 6. Sertraline Cohort
    Intervention: Drug: Sertraline
  • 7. Venlafaxine Cohort
    Intervention: Drug: Venlafaxine
  • 8. Tianeptine Cohort
    Intervention: Drug: Tianeptine
  • 9. Vortioxetine Cohort
    Intervention: Drug: Vortioxetine
  • 10. Desvenlafaxine Cohort
    Intervention: Drug: Desvenlafaxine
  • 11. Bupropion Cohort
    Intervention: Drug: Bupropion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 22, 2020)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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*)
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04446039
Other Study ID Numbers B2061147
CAR-BIG Study ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020