Pharmacokinetics of SSRI/SNRI (Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine Reuptake Inhibitors) After Bariatric Surgery and the Effects on Clinical Course
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in SSRI/SNRI blood levels after surgery
研究概览
简要总结
Psychiatric disorders and treatment with antidepressants SSRI/SNRI (selective serotonin reuptake inhibitors/ serotonin-norepinephrine reuptake inhibitors) are common in people with morbid obesity who are candidates for bariatric surgery. Although longitudinal assessments reveal positive effects of bariatric surgery on quality of life and mood, depressive disorders may also deteriorate after bariatric surgery. There is few and inconsistent data about the postoperative pharmacokinetics of SSRI/SNRI. The aims of our study were to provide comprehensive data about the postoperative bioavailability of SSRI/SNRI, and the clinical effects on the course of depression.
详细描述
Prospective multicenter study including 63 patients (i.e. 46 participants in the bariatric surgery group, and 17 participants in the conservative group as controls) with morbid obesity and therapy with SSRI/SNRI: participants filled the Beck Depression Inventory II (BDI) questionnaire, and plasma levels of SSRI/SNRI were measured by HPLC (High Performance Liquid Chromatography), preoperatively (T0), 4 weeks (T1) and 6 months (T2) postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age >18 years
- •Existing antidepressant drug therapy with SSRI or SNRI
- •Written informed consent
排除标准
- •Taking other psychotropic drugs than SSRI/SNRI
- •Active drug addiction or psychosis
- •Severe depression (BDI score >30)
- •Suicidality at the beginning of the study
- •Gastrointestinal malabsorption
- •Pregnancy
结局指标
主要结局
Change in SSRI/SNRI blood levels after surgery
时间窗: Change in SSRI/SNRI blood levels at 4 weeks and 6 months after surgery
Blood analysis: blood samples were drawn at the predefined time period (corresponding to the presumed Tmax) after ingesting the SSRI/SNRI
Change in BDI (Beck Depression Inventory) II questionnaire scores after surgery
时间窗: Change in BDI II questionnaire scores at 4 weeks and 6 months after surgery
The BDI is a psychological test that measures the severity of depressive symptoms or depression. The test procedure is a self-assessment measure including 21 questions on a four-level scale with values from 0 to 3 in terms of occurrence and intensity, providing a sum value between 0 and 63. Based on this value, it is possible to determine whether the person is non-depressed (0), minimally depressed, mildly depressed, moderate to severely depressed or severely depressed (63).
次要结局
未报告次要终点