Clinical trial NCT00876226: Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Official title: Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: Citalopram
Pharmacokinetics
Short Bowel Syndrome
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure plasma concentration of citalopram
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Ashish Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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