Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
NCT04446039
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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)
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

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
- Montreal, Quebec
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 :
| ||||||
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 |
| ||||||
Study Groups/Cohorts |
| ||||||
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 | 1 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | September 1, 2021 | ||||||
Estimated Primary Completion Date | September 1, 2021 (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:
Exclusion Criteria Patients meeting any of the following criteria will not be included in the study:
| ||||||
Sex/Gender |
| ||||||
Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
| ||||||
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 |
| ||||||
IPD Sharing Statement |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor | Pfizer | ||||||
Collaborators | Not Provided | ||||||
Investigators |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | June 2020 |