Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Ashish Sharma, MD, University of Nebraska Identifier:
First received: April 2, 2009
Last updated: May 19, 2014
Last verified: May 2014
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.

Condition Intervention
Short Bowel Syndrome
Drug: Citalopram

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Measure plasma concentration of citalopram [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.


Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00876226

United States, Nebraska
University of Nebraska Medical Center Omaha, Nebraska 68198-8470
Omaha, Nebraska, United States, 68198-8470
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-8470
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Ashish Sharma, MD University of Nebraska
  More Information


Responsible Party: Ashish Sharma, MD, Associate Professor, University of Nebraska Identifier: NCT00876226     History of Changes
Other Study ID Numbers: 479-07-FB 
Study First Received: April 2, 2009
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Short Bowel Syndrome

Additional relevant MeSH terms:
Short Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Pathologic Processes
Postoperative Complications
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 26, 2016