Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Measure plasma concentration of citalopram
研究概览
简要总结
This study will look at how the body interacts with citalopram in adult participants with short bowel syndrome. While information on depression in patients with short bowel syndrome is sparse, the investigators' experience is that these patients have a high incidence of depression and should benefit from a drug intervention.
详细描述
This prospective study will determine the pharmacokinetic parameters of citalopram in 12 adult patients with short bowel syndrome. While data on the prevalence of depression in patients with short bowel syndrome is sparse, the investigators' experience is that these patients have a high incidence of depression and should benefit from a psychopharmacological intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between the ages 19-65 years.
- •Subjects must have less than 200cm of functional small intestine.
- •Subjects must be at least one month post bowel resection.
排除标准
- •Subjects less than 19 years or more than 65 years of age.
- •Pregnant or breastfeeding women.
- •Known hypersensitivity to citalopram or other SSRIs.
- •Diagnosis of depression using MINI (Mini International Neuropsychiatric Interview).
- •Ongoing antidepressant therapy.
- •Evidence of cirrhosis (Child-Pugh stages B or C) or evidence of significant liver impairment defined as liver enzymes elevations greater that 2.5 times the upper limit of normal.
- •Suicidal ideation.
- •Bipolar disorder.
- •Known history of seizures.
- •Evidence of hyponatremia.
研究组 & 干预措施
Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Citalopram pharmacokinetics will be studies in subjects with short bowel syndrome.
Citalopram 20mg orally will be given to the subjects and on the seventh day blood will be drawn at hours 0,1,2,3,4,6,8,12,16 and 24 hours post-dose.
干预措施: Citalopram (Drug)
结局指标
主要结局
Measure plasma concentration of citalopram
时间窗: Seven days
Plasma concentration of citalopram (ng/mL) on the seventh day of treatment. Blood will be drawn at hours 0,1,2,3,4,6,8,12,16 and 24 hours post-dose.
次要结局
未报告次要终点