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Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876226
Recruitment Status : Withdrawn
First Posted : April 6, 2009
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):
Ashish Sharma, MD, University of Nebraska

Brief Summary:
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 or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: Citalopram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : April 2013

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.

Primary Outcome Measures :
  1. Measure plasma concentration of citalopram [ Time Frame: Seven days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876226

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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
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Principal Investigator: Ashish Sharma, MD University of Nebraska

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Responsible Party: Ashish Sharma, MD, Associate Professor, University of Nebraska Identifier: NCT00876226    
Other Study ID Numbers: 479-07-FB
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Keywords provided by Ashish Sharma, MD, University of Nebraska:
Short Bowel Syndrome
Additional relevant MeSH terms:
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Short Bowel Syndrome
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs