N/A
N=370,212
Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
Major Depression
Bottom Line
View on ClinicalTrials.gov: NCT04446039 ↗Enrolled (actual)
370,212
Serious AEs
—
Results posted
Dec 2024
Primary outcome: Primary: Medication Possession Ratio (MPR) During First 180 Days of Treatment — 0.47; 0.49; 0.46; 0.48 Ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Escitalopram (Drug); Paroxetine (Drug); Fluoxetine (Drug); Mirtazapine (Drug); Duloxetine (Drug); Sertraline (Drug); Venlafaxine (Drug); Tianeptine (Drug); Vortioxetine (Drug); Desvenlafaxine (Drug); Bupropion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Possession Ratio (MPR) During First 180 Days of Treatment |
0.47; 0.49; 0.46; 0.48; 0.47; 0.50 | — |
| PRIMARY Persistence During First 180 Days of Treatment |
76.11; 79.83; 74.17; 77.34; 71.66; 79.80 | — |
| PRIMARY Percentage of Participants Who Discontinued Treatment in the First 90 Days From the Index Date |
14.82; 15.16; 15.14; 14.87; 17.04; 14.04 | — |
| PRIMARY Percentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%]) |
30.31; 33.18; 27.92; 31.48; 30.73; 33.39 | — |
| PRIMARY Percentage of Participants Experiencing Recurrence During the Acute Treatment Phase |
16.42; 17.84; 15.64; 16.73; 17.97; 17.73 | — |
| PRIMARY Percentage of Participants Experiencing Recurrence After the Acute Treatment Phase |
22.71; 23.58; 23.74; 22.91; 25.48; 23.36 | — |
| PRIMARY Percentage of Participants With Adverse Events (AE) Within Maintenance Phase of Treatment |
6.08; 6.44; 4.29; 6.09; 9.59; 6.48 | — |
| PRIMARY Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment Phase |
44.19; 10.1; 12.15; 8.89; 2.3; 3.21 | — |
| PRIMARY Average Daily Dosage at Index Date |
6.34; 13.01; 16.30; 38.75; 34.80; 54.11 | — |
| PRIMARY Average Daily Dosage During the Acute Treatment Phase |
7.94; 15.27; 19.07; 49.91; 37.51; 69.12 | — |
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.
Eligibility Criteria
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
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*)
Data sourced from ClinicalTrials.gov (NCT04446039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.