Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 370,212
- 试验地点
- 1
- 主要终点
- Medication Possession Ratio (MPR) During First 180 Days of Treatment
研究概览
简要总结
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.
详细描述
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 :
- Explore baseline characteristics and drug utilization patterns of 11 commonly used antidepressant therapy during 90 days of acute treatment phase
- Explore drug utilization patterns such as therapy changes, medication compliance and recurrence relationship, and risk of adverse outcomes during maintenance phase
- Choice of antidepressants and drug utilization patterns in patients with various comorbidities
- The relationship of non-pharmacologic treatment and discontinuation, medication compliance
- Choice of antidepressants by non-psychiatric specialty
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1. Escitalopram Cohort
干预措施: Escitalopram (Drug)
2. Paroxetine Cohort
干预措施: Paroxetine (Drug)
3. Fluoxetine Cohort
干预措施: Fluoxetine (Drug)
4. Mirtazapine Cohort
干预措施: Mirtazapine (Drug)
5. Duloxetine Cohort
干预措施: Duloxetine (Drug)
6. Sertraline Cohort
干预措施: Sertraline (Drug)
7. Venlafaxine Cohort
干预措施: Venlafaxine (Drug)
8. Tianeptine Cohort
干预措施: Tianeptine (Drug)
9. Vortioxetine Cohort
干预措施: Vortioxetine (Drug)
10. Desvenlafaxine Cohort
干预措施: Desvenlafaxine (Drug)
11. Bupropion Cohort
干预措施: Bupropion (Drug)
结局指标
主要结局
Medication Possession Ratio (MPR) During First 180 Days of Treatment
时间窗: From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)
MPR= Days of medication possession from the prescriptions filled in the 180 days divided by (180 days plus + extra days of drug supply from the last prescription fill during the 180 days). MPR by each index drug including escitalopram, paroxetine, fluoxetine, mirtazapine, duloxetine, sertraline, venlafaxine, tianeptine, vortioxetine, desvenlafaxine and bupropion is reported in this outcome measure. Index date was first prescription date of study drugs during intake period.
Persistence During First 180 Days of Treatment
时间窗: From index date (anytime between 01-Jan-2018 to 31-Dec-2019) up to 180 days of treatment (data collected and observed retrospectively)
Persistence was defined as the average length of treatment on the index drugs (escitalopram, paroxetine, fluoxetine, mirtazapine, duloxetine, sertraline, venlafaxine, tianeptine, vortioxetine, desvenlafaxine and bupropion), allowing 14-day permissible gap. Index date was first prescription date of study drugs during intake period.
Percentage of Participants Who Discontinued Treatment in the First 90 Days From the Index Date
时间窗: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
Percentage of participants who discontinued the treatment in first 90 days from the index date is reported in this outcome measure. Index date was the first prescription date of study treatment during the intake period.
Percentage of Participants Who Adhered to Treatment Measured by MPR (More Than or Equal to [>=] 75 Percent [%])
时间窗: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 180 days of treatment (data collected and observed retrospectively)
Adherence was defined when MPR \>= 75%. MPR = (Days of medication possession from the prescriptions filled in the 180 days) / (180 days + extra days of drug supply from the last prescription fill during the 180 days. Index date was the first prescription date of study drugs during the intake period.
Percentage of Participants Experiencing Recurrence During the Acute Treatment Phase
时间窗: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
Recurrence during the acute treatment phase was defined as either one of the following: 1) Inpatient episode with a diagnosis code. 2) Inpatient episodes via the department of psychiatry or emergency medicine. 3) Inpatient episode via nursing hospital. 4) Emergency room visit with a diagnosis code. 5) Suicide attempt. Acute phase considered as the first 90-day period starting from the index date. Index date was the first prescription date of study treatment during the intake period. Diagnosis codes used for inclusion were: F06.3-Organic mood(affective) disorders, F32\*- Depressive episode, F33\*- Recurrent depressive disorder, F34.1- Neurotic depression, F38.1- Other recurrent mood(affective) disorders, F41.2- Mixed anxiety and depressive disorder.
Percentage of Participants Experiencing Recurrence After the Acute Treatment Phase
时间窗: From day 91 to day 180 from the index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)
Recurrence was defined as either one of the following: 1) Inpatient episode with a diagnosis code. 2) Inpatient episodes via the department of psychiatry or emergency medicine. 3) Inpatient episode via nursing hospital. 4) Emergency room visit with a diagnosis code. 5) Suicide attempt; antidepressant prescription after 30 days of drug holiday. Acute phase considered as the first 90-day period starting from the index date. Index date was the first prescription date of study treatment during the intake period.
Percentage of Participants With Adverse Events (AE) Within Maintenance Phase of Treatment
时间窗: 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)
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. Maintenance phase was during the second 90-day period (91 to 180 days) starting from the index date. Index date was the first prescription date of study treatment during the intake period. Index date was the first prescription date of study treatment during the intake period.
Percentage of Prescriptions for Commonly Used Antidepressants in Acute Treatment Phase
时间窗: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
Percentage of prescriptions for commonly used antidepressants in acute treatment phase were assessed. Acute treatment phase was during the first 90-day period starting from the index date. Index date was the first prescription date of study treatment during the intake period.
Average Daily Dosage at Index Date
时间窗: At index date (anytime between 01-Jan-2018 to 30-Jun-2019) (data collected and observed retrospectively)
Index date was the first prescription date of study treatment during the intake period.
Average Daily Dosage During the Acute Treatment Phase
时间窗: From the index date (anytime between 01-Jan-2018 to 30-Jun-2019) up to 90 days of treatment (data collected and observed retrospectively)
Acute treatment phase was during the first 90-day period starting from the index date.
次要结局
未报告次要终点