Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00876226
• Other study ID #: 0479-07-FB
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2010
• Est. completion date: September 11, 2012

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at how the body interacts with citalopram in adult participants with short bowel syndrome. While information on 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 drug intervention.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 11, 2012
• Est. primary completion date: September 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

References & Publications (10)

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

Baumann P. Pharmacology and pharmacokinetics of citalopram and other SSRIs. Int Clin Psychopharmacol. 1996 Mar;11 Suppl 1:5-11. doi: 10.1097/00004850-199603001-00002. — View Citation

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. doi: 10.1177/0148607190014003326. — View Citation

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. doi: 10.1016/s1091-255x(01)80030-5. — View Citation

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. doi: 10.1016/s0163-8343(96)00079-5. — View Citation

Edes TE. Clinical management of short-bowel syndrome. Enhancing the patient's quality of life. Postgrad Med. 1990 Sep 15;88(4):91-5. doi: 10.1080/00325481.1990.11704755. — View Citation

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. doi: 10.1016/0163-8343(80)90080-8. — View Citation

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. doi: 10.2165/00003495-199141030-00008. — View Citation

Pollock BG. Citalopram: a comprehensive review. Expert Opin Pharmacother. 2001 Apr;2(4):681-98. doi: 10.1517/14656566.2.4.681. — View Citation

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. doi: 10.2165/00003088-200443140-00001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure plasma concentration of citalopram	Plasma concentration of citalopram (ng/mL) on the seventh day of treatment. Blood will be drawn at hours 0,1,2,3,4,6,8,12,16 and 24 hours post-dose.	Seven days