NCT04446039

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

Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 370,212 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-04
• Primary completion: 2022-11-03
• Completion: 2022-11-03
• First posted: 2020-06-24
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study