- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876226
Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome
Study to Determine Steady-state Level of Citalopram Pharmacokinetic Parameters in Patients With Short Bowel Syndrome
Study Overview
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198-8470
- University of Nebraska Medical Center Omaha, Nebraska 68198-8470
-
Omaha, Nebraska, United States, 68198-8470
- University of Nebraska Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure plasma concentration of citalopram
Time Frame: Seven days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashish Sharma, MD, University of Nebraska
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pollock BG. Citalopram: a comprehensive review. Expert Opin Pharmacother. 2001 Apr;2(4):681-98. doi: 10.1517/14656566.2.4.681.
- Baumann P. Clinical pharmacokinetics of citalopram and other selective serotonergic reuptake inhibitors (SSRI). Int Clin Psychopharmacol. 1992 Jun;6 Suppl 5:13-20.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Postoperative Complications
- Disease
- Gastrointestinal Diseases
- Intestinal Diseases
- Malabsorption Syndromes
- Syndrome
- Short Bowel Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Selective Serotonin Reuptake Inhibitors
- Citalopram
Other Study ID Numbers
- 0479-07-FB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Short Bowel Syndrome
-
Marathon Pharmaceuticals, LLCWithdrawnShort Bowel Syndrome | Short Gut Syndrome | SBS | Short Gut | Short BowelUnited States
-
Central Hospital, Nancy, FranceBeaujon Hospital; Société Francophone Nutrition Clinique et MétabolismeUnknownSBS - Short Bowel SyndromeFrance
-
TakedaCompletedShort Bowel Syndrome (SBS)Brazil
-
TakedaRecruitingShort Bowel Syndrome (SBS)Canada
-
GlyPharma TherapeuticsVectivBio AGCompletedSBS - Short Bowel SyndromeDenmark
-
ShireRecruitingShort Bowel Syndrome (SBS)United States
-
Marathon Pharmaceuticals, LLCWithdrawnShort Bowel Syndrome | Short Gut Syndrome | SBS | Short GutUnited States
-
University of Texas Southwestern Medical CenterChildren's Hospital of PhiladelphiaNot yet recruitingShort Gut Syndrome
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaRecruiting
-
University of MiamiQOL Medical, LLCRecruitingShort Gut SyndromeUnited States
Clinical Trials on Citalopram
-
A.O. Ospedale Papa Giovanni XXIIIUnknownAcute Appendicitis Without PeritonitisItaly
-
Istituto Auxologico ItalianoRecruiting
-
St. Luke's-Roosevelt Hospital CenterForest LaboratoriesCompleted
-
Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
China Medical University HospitalNational Science Council, TaiwanCompletedDepression | Major Depression | Major Depressive DisorderTaiwan
-
Sunnybrook Health Sciences CentreOntario Mental Health FoundationCompleted
-
Institut National de la Santé Et de la Recherche...Completed
-
Hadassah Medical OrganizationUnknown
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases
-
Mclean HospitalCompletedMajor Depressive Disorder | MDD | CitalopramUnited States