The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
NCT ID: NCT01317147
Last Updated: 2011-03-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
12 participants
Study Classification
OBSERVATIONAL
Study Start Date
2007-08-31
Study Completion Date
2010-08-31
Brief Summary
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The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.
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Detailed Description
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Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively. Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies (PK) preoperatively. Maximum concentration (CMAX), time to CMAX (TMAX), and Area Under Concentration/Time curve (AUC) were determined. PK studies were repeated at one, six, and twelve months post-operatively. PK data were corrected for dose at each study time point. The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms.
Conditions
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Gastric Bypass
Depression
Anxiety Disorder
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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Gastric bypass patients
Roux-en-Y gastric bypass (RYGBP)
Intervention Type
PROCEDURE
Interventions
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Roux-en-Y gastric bypass (RYGBP)
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Able to tolerate general anesthesia
* Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months
* Able to provide informed consent
* Cleared for surgery by primary care MD, dietician, and psychiatrist
* SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks
* Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months
* Able to provide informed consent
* Cleared for surgery by primary care MD, dietician, and psychiatrist
* SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks
Exclusion Criteria
* pregnancy
* Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup
* Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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American Society for Metabolic and Bariatric Surgery
OTHER
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
lead
Responsible Party
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University of Pittsburgh School of Medicine
Principal Investigators
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Giselle Hamad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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BACKGROUND
Ruz M, Carrasco F, Rojas P, Codoceo J, Inostroza J, Rebolledo A, Basfi-fer K, Csendes A, Papapietro K, Pizarro F, Olivares M, Sian L, Westcott JL, Hambidge KM, Krebs NF. Iron absorption and iron status are reduced after Roux-en-Y gastric bypass. Am J Clin Nutr. 2009 Sep;90(3):527-32. doi: 10.3945/ajcn.2009.27699. Epub 2009 Jul 22.
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Roerig JL, Steffen K, Zimmerman C, Mitchell JE, Crosby RD, Cao L. Preliminary comparison of sertraline levels in postbariatric surgery patients versus matched nonsurgical cohort. Surg Obes Relat Dis. 2012 Jan-Feb;8(1):62-6. doi: 10.1016/j.soard.2010.12.003. Epub 2010 Dec 15.
Reference Type
BACKGROUND
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BACKGROUND
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Schauer PR, Ikramuddin S, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000 Oct;232(4):515-29. doi: 10.1097/00000658-200010000-00007.
Reference Type
BACKGROUND
Gubbins PO, Bertch KE. Drug absorption in gastrointestinal disease and surgery. Clinical pharmacokinetic and therapeutic implications. Clin Pharmacokinet. 1991 Dec;21(6):431-47. doi: 10.2165/00003088-199121060-00004.
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Magee SR, Shih G, Hume A. Malabsorption of oral antibiotics in pregnancy after gastric bypass surgery. J Am Board Fam Med. 2007 May-Jun;20(3):310-3. doi: 10.3122/jabfm.2007.03.060177.
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Wills SM, Zekman R, Bestul D, Kuwajerwala N, Decker D. Tamoxifen malabsorption after Roux-en-Y gastric bypass surgery: case series and review of the literature. Pharmacotherapy. 2010 Feb;30(2):217. doi: 10.1592/phco.30.2.217.
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BACKGROUND
Brandacher G, Winkler C, Aigner F, Schwelberger H, Schroecksnadel K, Margreiter R, Fuchs D, Weiss HG. Bariatric surgery cannot prevent tryptophan depletion due to chronic immune activation in morbidly obese patients. Obes Surg. 2006 May;16(5):541-8. doi: 10.1381/096089206776945066.
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BACKGROUND
Kinzl JF, Schrattenecker M, Traweger C, Mattesich M, Fiala M, Biebl W. Psychosocial predictors of weight loss after bariatric surgery. Obes Surg. 2006 Dec;16(12):1609-14. doi: 10.1381/096089206779319301.
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BACKGROUND
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BACKGROUND
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BACKGROUND
Sanchez-Santos R, Del Barrio MJ, Gonzalez C, Madico C, Terrado I, Gordillo ML, Pujol J, Moreno P, Masdevall C. Long-term health-related quality of life following gastric bypass: influence of depression. Obes Surg. 2006 May;16(5):580-5. doi: 10.1381/096089206776945084.
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BACKGROUND
Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
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BACKGROUND
Reis M, Aberg-Wistedt A, Agren H, Akerblad AC, Bengtsson F. Compliance with SSRI medication during 6 months of treatment for major depression: an evaluation by determination of repeated serum drug concentrations. J Affect Disord. 2004 Nov 1;82(3):443-6. doi: 10.1016/j.jad.2004.02.003.
Reference Type
BACKGROUND
Other Identifiers
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PRO07120162
Identifier Type: -
Identifier Source: org_study_id
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