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Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT00876226
Recruitment Status : Withdrawn
First Posted : April 6, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Ashish Sharma, MD, University of Nebraska

Tracking Information
First Submitted Date  ICMJE April 2, 2009
First Posted Date  ICMJE April 6, 2009
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2009)
Measure plasma concentration of citalopram [ Time Frame: Seven days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00876226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Official Title  ICMJE Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Short Bowel Syndrome
Intervention  ICMJE 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.

Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2009)
12
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00876226
Other Study ID Numbers  ICMJE 479-07-FB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ashish Sharma, MD, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashish Sharma, MD University of Nebraska
PRS Account University of Nebraska
Verification Date May 2014

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