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.
Procedure: Roux-en-Y gastric bypass (RYGBP)
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors|
|Study Start Date:||August 2007|
|Study Completion Date:||August 2010|
|Gastric bypass patients||Procedure: Roux-en-Y gastric bypass (RYGBP)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317147
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Giselle Hamad, MD||University of Pittsburgh|