Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

NCT00876226 | Withdrawn DMC

• 1 other identifier: 0479-07-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Short Bowel Syndrome

Keywords

Citalopram; Pharmacokinetics; Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

EXPERIMENTAL

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.

Drug: Citalopram

Interventions

Citalopram DRUG

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.

Also known as: Celexa

Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Related Publications (10)

• 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.

  PMID: 2204906 BACKGROUND

• 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.

  PMID: 11331480 BACKGROUND

• 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.

  PMID: 6780408 BACKGROUND

• 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.

  PMID: 8937920 BACKGROUND

• 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.

  PMID: 15530127 BACKGROUND

• 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.

  PMID: 2112651 BACKGROUND

• 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.

  PMID: 8732438 BACKGROUND

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

  PMID: 11336616 BACKGROUND

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

  PMID: 1431018 BACKGROUND

• 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.

  PMID: 1711447 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ashish Sharma, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 6, 2009
• Study Start: May 1, 2010
• Primary Completion: September 11, 2012
• Study Completion: September 11, 2012
• Last Updated: August 14, 2023

Record last verified: 2023-08