Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876226

Enrollment

Registered

2009-04-06

Start date

2010-05-01

Completion date

2012-09-11

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

Keywords

Citalopram, Pharmacokinetics, Short Bowel Syndrome

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.

Interventions

DRUGCitalopram

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026