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...
Date First Received: April 2, 2009
Last Updated: April 3, 2009
Verified by: University of Nebraska, April 2009
Clinical Trial Phase: N/A | Start Date: June 2009
Overall Status: Not yet recruiting
Estimated Enrollment: 12
Brief Summary
Official Title: “Study to Determine Steady-State Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Health Services Research, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Study Primary Completion Date: September 2009
Intervention(s) in this Clinical Trial
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- Measure plasma concentration of citalopram
- Time Frame: Seven days
Safety Issue?: Yes
- Time Frame: Seven days
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Nebraska
Overall Clinical Trial Officials and Contacts
Ashish Sharma, MD Principal Investigator University of Nebraska
Overall Contact: Ashish Sharma, MD 402-552-2112 asharma2@unmc.edu
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 04, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00876226
Study ID Number: 479-07-FB
ClinicalTrials.gov Identifier: NCT00876226
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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