A Phase 3 interventional study of Sertraline in Roux en Y Gastric Bypass Surgery, sponsored by North Dakota State University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by North Dakota State University · Phase 3 and Interventional
This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.
North Dakota State University is the lead sponsor of 21 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Sertraline
Single dose sertraline 100 mg, tablet and solution
Also known as: Zoloft
Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC)
The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.
Time frame: 72 hour intervals
Bioavailability comparison between sertraline tablet and sertraline liquid
To characterize the relative bioavailability of the tablet formulation of sertraline 100mg as compared to a reference dose of the liquid preparation of sertraline 100mg before and at three and 12 months following RYGBP.
Time frame: 72 hours
Body Composition and Weight
Chanes in body compsition and weight will be correlated with changes observed in sertraline pharmacokinetic parameters and will be considered exploratory.
Time frame: 72 hours
Hepatic Function
To assess the area under the curve (AUC) ratio of N-desmethylsertraline to sertraline as a measure of hepatic function over time.
Time frame: 72 hours
Plasma Protein Concentrations
To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels.
Time frame: 72 hours
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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North Dakota State University