Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Drug: Citalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Mania. Known history of seizures. Evidence of hyponatremia.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome<br>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. | Drug: Citalopram<br>* 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.<br>* Other names: Celexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure plasma concentration of citalopram | 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. | Seven days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citalopram, Pharmacokinetics, Short Bowel Syndrome