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Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Short Bowel Syndrome

Intervention: Citalopram (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
Ashish Sharma, MD, Principal Investigator, Affiliation: University of Nebraska

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.

Clinical Details

Official title: Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Measure plasma concentration of citalopram

Eligibility

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

University of Nebraska Medical Center, Omaha, Nebraska 68198-8470, United States

University of Nebraska Medical Center Omaha, Nebraska 68198-8470, Omaha, Nebraska 68198-8470, United States

Additional Information

Related 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.

Starting date: May 2010
Last updated: May 19, 2014

Page last updated: August 23, 2015

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