Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Not Applicable

Withdrawn

• Conditions: Short Bowel Syndrome
• Interventions: Drug: Citalopram

• Registration Number: NCT00876226
• Lead Sponsor: University of Nebraska

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Study Start: 2010-05-01
• Primary Completion: 2012-09-11
• Study Completion: 2012-09-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome	Citalopram	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.

Primary Outcome Measures

Name	Time	Method
Measure plasma concentration of citalopram	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.