The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.
详细描述
Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively. Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies (PK) preoperatively. Maximum concentration (CMAX), time to CMAX (TMAX), and Area Under Concentration/Time curve (AUC) were determined. PK studies were repeated at one, six, and twelve months post-operatively. PK data were corrected for dose at each study time point. The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to tolerate general anesthesia
- •Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months
- •Able to provide informed consent
- •Cleared for surgery by primary care MD, dietician, and psychiatrist
- •SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks
排除标准
- •pregnancy
- •Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup