Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Ashish Sharma, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00876226
First received: April 2, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876226

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

Publications:

Responsible Party: Ashish Sharma, MD, Associate Professor, University of Nebraska
ClinicalTrials.gov 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:
Citalopram
Pharmacokinetics
Short Bowel Syndrome

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 24, 2014