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

Sponsored by:	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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Study to Determine Steady-State Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome

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:	June 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (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
Omaha, Nebraska, United States, 68198-8470

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:	The Nebraska Medical Center ( Ashish Sharma )
Study ID Numbers:	479-07-FB
Study First Received:	April 2, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876226 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:

Citalopram
Pharmacokinetics
Short Bowel Syndrome

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Gastrointestinal Diseases
Psychotropic Drugs
Short Bowel Syndrome
Cholinergic Agents
Intestinal Diseases
Citalopram
Serotonin Uptake Inhibitors

Serotonin
Muscarinic Antagonists
Digestive System Diseases
Postoperative Complications
Malabsorption Syndromes
Peripheral Nervous System Agents
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Antidepressive Agents, Second-Generation

Dexetimide
Antidepressive Agents
Disease
Short Bowel Syndrome
Intestinal Diseases
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Digestive System Diseases
Serotonin Agents
Postoperative Complications
Autonomic Agents
Malabsorption Syndromes
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009