Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Primary Purpose
Short Bowel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citalopram
Sponsored by
About this trial
This is an interventional health services research trial for Short Bowel Syndrome focused on measuring Citalopram, Pharmacokinetics, Short Bowel Syndrome
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00876226
Brief Title
Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Official Title
Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
September 11, 2012 (Actual)
Study Completion Date
September 11, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Citalopram, Pharmacokinetics, Short Bowel Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure plasma concentration of citalopram
Description
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.
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish Sharma, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
2204906
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
6780408
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.
Results Reference
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PubMed Identifier
8937920
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.
Results Reference
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PubMed Identifier
15530127
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.
Results Reference
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PubMed Identifier
2112651
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.
Results Reference
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PubMed Identifier
8732438
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.
Results Reference
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PubMed Identifier
11336616
Citation
Pollock BG. Citalopram: a comprehensive review. Expert Opin Pharmacother. 2001 Apr;2(4):681-98. doi: 10.1517/14656566.2.4.681.
Results Reference
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PubMed Identifier
1431018
Citation
Baumann P. Clinical pharmacokinetics of citalopram and other selective serotonergic reuptake inhibitors (SSRI). Int Clin Psychopharmacol. 1992 Jun;6 Suppl 5:13-20.
Results Reference
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PubMed Identifier
1711447
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.
Results Reference
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Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
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