Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome - Full Text View

Sponsor:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00876226

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:

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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 ]

Estimated Enrollment:	12
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:

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

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

Contacts

Contact: Ashish Sharma, MD

402-552-2112 ext 2168

asharma2@unmc.edu

Locations

United States, Nebraska
University of Nebraska Medical Center	Not yet recruiting
Omaha, Nebraska, United States, 68198-8470
Contact: Ashish Sharma, MD 402-552-2112 ext 2168 asharma2@unmc.edu
Principal Investigator: Ashish Sharma, MD
University of Nebraska Medical Center Omaha, Nebraska 68198-8470	Recruiting
Omaha, Nebraska, United States, 68198-8470
Contact: Ashish Sharma, MD 402-552-2112 asharma2@unmc.edu

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator:

Ashish Sharma, MD

University of Nebraska

More Information

Publications:

Edes TE. Clinical management of short-bowel syndrome. Enhancing the patient's quality of life. Postgrad Med. 1990 Sep 15;88(4):91-5. Review.

Cicalese L, Rastellini C, Sileri P, Abcarian H, Benedetti E. Segmental living related small bowel transplantation in adults. J Gastrointest Surg. 2001 Mar-Apr;5(2):168-72; discussion 173.

Gulledge AD, Gipson WT, Steiger E, Hooley R, Srp F. Home parenteral nutrition for the short bowel syndrome. Psychological issues. Gen Hosp Psychiatry. 1980 Dec;2(4):271-81.

DiMartini A, Fitzgerald MG, Magill J, Funovitz M, Abu-Elmagd K, Furukawa H, Todo S. Psychiatric evaluations of small intestine transplantation patients. Gen Hosp Psychiatry. 1996 Nov;18(6 Suppl):25S-29S.

Severijnen R, Bayat N, Bakker H, Tolboom J, Bongaerts G. Enteral drug absorption in patients with short small bowel : a review. Clin Pharmacokinet. 2004;43(14):951-62. Review.

Broyles JE, Brown RO, Self TH, Frederick RC, Luther RW. Nortriptyline absorption in short bowel syndrome. JPEN J Parenter Enteral Nutr. 1990 May-Jun;14(3):326-7.

Baumann P. Pharmacology and pharmacokinetics of citalopram and other SSRIs. Int Clin Psychopharmacol. 1996 Mar;11 Suppl 1:5-11. Review.

Pollock BG. Citalopram: a comprehensive review. Expert Opin Pharmacother. 2001 Apr;2(4):681-98. Review.

Baumann P. Clinical pharmacokinetics of citalopram and other selective serotonergic reuptake inhibitors (SSRI). Int Clin Psychopharmacol. 1992 Jun;6 Suppl 5:13-20. Review.

Milne RJ, Goa KL. Citalopram. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depressive illness. Drugs. 1991 Mar;41(3):450-77. Review.

Responsible Party:	Ashish Sharma, The Nebraska Medical Center
ClinicalTrials.gov Identifier:	NCT00876226 History of Changes
Other Study ID Numbers:	479-07-FB
Study First Received:	April 2, 2009
Last Updated:	August 2, 2011
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 February 09, 2012