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

Pfizer

Status: Completed

Conditions: Major Depression

Treatments: Drug: Desvenlafaxine; Drug: Paroxetine; Drug: Duloxetine; Drug: Escitalopram; Drug: Sertraline; Drug: Tianeptine; Drug: Venlafaxine; Drug: Vortioxetine; Drug: Mirtazapine; Drug: Fluoxetine; Drug: Bupropion

Study type: Observational

Funder types: Industry

Identifiers

NCT04446039

CAR-BIG Study (Other Identifier)

B2061147

Details and patient eligibility

About

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.

Full 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

Enrollment: 370,212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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*)

Trial design

370,212 participants in 11 patient groups

1. Escitalopram Cohort

Treatment:

Drug: Escitalopram

2. Paroxetine Cohort

Treatment:

Drug: Paroxetine

3. Fluoxetine Cohort

Treatment:

Drug: Fluoxetine

4. Mirtazapine Cohort

Treatment:

Drug: Mirtazapine

5. Duloxetine Cohort

Treatment:

Drug: Duloxetine

6. Sertraline Cohort

Treatment:

Drug: Sertraline

7. Venlafaxine Cohort

Treatment:

Drug: Venlafaxine

8. Tianeptine Cohort

Treatment:

Drug: Tianeptine

9. Vortioxetine Cohort

Treatment:

Drug: Vortioxetine

10. Desvenlafaxine Cohort

Treatment:

Drug: Desvenlafaxine

11. Bupropion Cohort

Treatment:

Drug: Bupropion