Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00876226
First received: April 2, 2009
Last updated: August 2, 2011
Last verified: August 2011

April 2, 2009
August 2, 2011
May 2010
December 2012   (final data collection date for primary outcome measure)
Measure plasma concentration of citalopram [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00876226 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Short Bowel Syndrome
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.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
April 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years to 65 Years
No
Contact: Ashish Sharma, MD 402-552-2112 ext 2168 asharma2@unmc.edu
United States
 
NCT00876226
479-07-FB
Yes
Ashish Sharma, The Nebraska Medical Center
University of Nebraska
Not Provided
Principal Investigator: Ashish Sharma, MD University of Nebraska
University of Nebraska
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP