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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Withdrawn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
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 2, 2009
    Last Updated
    August 9, 2023
    Sponsor
    University of Nebraska
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    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
    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.
    Results Reference
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    PubMed Identifier
    11331480
    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.
    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.
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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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