Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,586
- 试验地点
- 1
- 主要终点
- 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
研究概览
简要总结
This work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. The methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the Vivli trials resource) and non-experimental data from the Duke University Health System electronic health record and the Johns Hopkins Health System electronic health record systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duke University Health System Electronic Health Record (EHR) System and Johns Hopkins Health System EHR System
- •Inclusion criteria:
- •All patients prescribed any Duloxetine or Vortioxetine in the health systems between 01/01/2015 - 12/31/
- •AND from patients with at least 1-year historical EHR data (burn-in period) without prescribing any of the two medications. During the burn-in period, patients should have at least one encounter in the system, and with no encounters during that time frame when they were prescribed Duloxetine or Vortioxetine.
- •AND patients age 18-65 years old at baseline.
排除标准
- •- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.
- •4 randomized controlled trials (RCTs)
- •Inclusion criteria:
- •Male or female
- •Age 18 years or older
- •Major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) classification code 296.3x
- •Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 26
- •Clinical Global Impression - Severity (CGI-S) scale score ≥ 4
研究组 & 干预措施
Duke Health System Electronic Health Record
Patients who received Duloxetine or Vortioxetine
干预措施: Duloxetine, Vortioxetine (Drug)
Randomized Controlled Trial 3 (NCT00672620)
Patients who received Duloxetine or Vortioxetine
干预措施: Duloxetine, Vortioxetine (Drug)
Johns Hopkins Health System Electronic Health Record
Patients who received Duloxetine or Vortioxetine
干预措施: Duloxetine, Vortioxetine (Drug)
Randomized Controlled Trial 1 (NCT01153009)
Patients who received Duloxetine or Vortioxetine
干预措施: Duloxetine, Vortioxetine (Drug)
Randomized Controlled Trial 2 (NCT01140906)
Patients who received Duloxetine or Vortioxetine
干预措施: Duloxetine, Vortioxetine (Drug)
Randomized Controlled Trial 4 (NCT00635219)
Patients who received Duloxetine or Vortioxetine
干预措施: Duloxetine, Vortioxetine (Drug)
结局指标
主要结局
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
时间窗: 6 months
Higher score indicates greater severity of major depressive disorder.
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
时间窗: 1 year
Higher score indicates greater severity of major depressive disorder.
次要结局
- Emergency room visits or inpatient admissions with diagnosis of depression or suicidality(6 months)
- Emergency room visits or inpatient admissions for any reason(6 months)
- Emergency room visits or inpatient admissions with diagnosis of depression or suicidality(1 year)
- Emergency room visits or inpatient admissions for any reason(1 year)