Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery; a Prospective Open Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Area under the concentration curve of sertraline
研究概览
简要总结
Volunteers with a prescription of oral sertraline who have been scheduled to bariatric surgery in either Norrköping/Sweden or Lindesberg/Sweden will be asked to participate in a observational study. The aim of this study is to evaluate the absorption and the effect and side effects of sertraline in volunteers 8 weeks before and 1, 6 and 12 months after bariatric surgery.
详细描述
The pharmacokinetic changes of sertraline after bariatric surgery are studied by assessing the exposition for sertraline in individuals with long term treatment by measuring the area under the curve (AUC0-τ) 8 weeks before and one, six and twelve months after bariatric surgery in 30 participants.
The effect of variation of sertraline concentration is studied by a psychiatric assessment of depressive symptoms and symptoms of anxiety disorder. The aim ist to study if there is a relation between changes in pharmacokinetics and effect of sertraline after bariatric surgery.
For the assessment of side effects a self-reporting scale is used. These participants are recruited consequentially with the aim to get equal numbers of patients with both most usual types of surgery in Sweden (laparoscopic RYGB and gastric sleeve).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo either gastric bypass or gastric sleeve surgery via surgeon clinics in Örebro or Norrköping
- •prescription of sertraline
- •since at least one month
- •planned to be continued at the time of inclusion
- •swedish speaking
排除标准
- •comorbidity with the consequence that the potential participant may not be able to complete the study
- •if participation should result in a high risk for patients health or safety
结局指标
主要结局
Change in Area under the concentration curve of sertraline
时间窗: 8 weeks before, 1, 6 and 12 month after bariatric surgery before sertraline intake and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 24 hours post dose
Changes in the area under sertraline serum concentration vs time curve (AUC(0-t))
Change in Montgomery-Åsberg-depression rating scale (MADRS-B)
时间窗: 8 weeks before, 1, 6 and 12 month after bariatric surgery
Assessment of depressive symptoms with a 10-items scale (Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, Suicidal Thoughts). Higher score indicates more depressive symptoms, each item spans over a score from 0 to 6; the overall score ranges from 0 to 60.
Change in Clinical Anxiety Scale
时间窗: 8 weeks before, 1, 6 and 12 month after bariatric surgery
Psychiatric assessment of symptoms of anxiety disorders with an 5-items-scale (Psychic tension, Ability to relax/muscular tension, Startle response/hyperarousability, Worrying, Apprehension). Every item has values between 0 (no symptoms) and 4 (marked symptoms). The overall score ranges from 0 to 20.Higher scores indicate higher anxiety symptoms.
次要结局
- Changes in the area under concentration vs time curve of desmethylsertraline(8 weeks before, 1, 6 and 12 month after bariatric surgerybefore sertraline intake and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 24 hours post dose)
研究者
Michael Andresen
Principal Investigator
Linkoeping University