Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

NCT ID: NCT00876226

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-01
• Study Completion Date: 2012-09-11

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.

Conditions

Short Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

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.

Group Type: EXPERIMENTAL

Citalopram

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Celexa

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashish Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

References

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Reference Type: BACKGROUND

PMID: 2204906 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 8732438 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11336616 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 1431018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1711447 (View on PubMed)

Other Identifiers

0479-07-FB

Identifier Type: -

Identifier Source: org_study_id