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The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

This study has been completed.
Sponsor:
Collaborator:
American Society for Metabolic and Bariatric Surgery
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01317147
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 15, 2011
March 15, 2011
August 2007
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No Changes Posted
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The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Bariatric surgery clinic- Morbidly obese patients seeking RYGB who met criteria for bariatric surgery (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with severe obesity-related comorbidities) and were received maintenance treatment with an SRI for primary mood or anxiety disorder.

  • Gastric Bypass
  • Depression
  • Anxiety Disorder
Procedure: Roux-en-Y gastric bypass (RYGBP)
Gastric bypass patients
Intervention: Procedure: Roux-en-Y gastric bypass (RYGBP)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2010
Not Provided

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

Exclusion Criteria:

  • pregnancy
  • Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01317147
PRO07120162
No
Giselle Hamad, MD Assistant Professor of Surgery, University of Pittsburgh School of Medicine
University of Pittsburgh
American Society for Metabolic and Bariatric Surgery
Principal Investigator: Giselle Hamad, MD University of Pittsburgh
University of Pittsburgh
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP