Clinical trial NCT04446039: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 370212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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\*)

Primary outcomes:
measure: Medication Possession Ratio (MPR) During First 180 Days of Treatment
timeFrame: From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)
measure: Persistence During First 180 Days of Treatment
timeFrame: From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)
measure: Percentage of Participants Who Discontinued Treatment in the First 90 Days From the Index Date
timeFrame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
measure: Percentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])
timeFrame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 180 days of treatment (data collected and observed retrospectively)
measure: Percentage of Participants Experiencing Recurrence During the Acute Treatment Phase
timeFrame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
measure: Percentage of Participants Experiencing Recurrence After the Acute Treatment Phase
timeFrame: From day 91 to day 180 from the index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)
measure: Percentage of Participants With Adverse Events (AE) Within Maintenance Phase of Treatment
timeFrame: 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)
measure: Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment Phase
timeFrame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
measure: Average Daily Dosage at Index Date
timeFrame: At index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)
measure: Average Daily Dosage During the Acute Treatment Phase
timeFrame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants on Monotherapy, Combination Therapy, Augmentation Therapy During Acute Treatment Phase
timeFrame: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
measure: Drug Utilization Pattern of Participants During 90-180 Days of Treatment
timeFrame: From 90 days to 180 days of treatment (data collected and observed retrospectively)
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: