Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	19 - 65
Updated:	5/5/2014
Start Date:	May 2010
End Date:	April 2013
Contact:	Ashish Sharma, MD
Email:	asharma2@unmc.edu
Phone:	402-552-2112

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

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.

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.

We found this trial at

sites

University of Nebraska Medical Center Omaha, Nebraska 68198-8470

Omaha, Nebraska 68198

from

Omaha, NE