Neuropsychiatric Research Institute
Fargo, North Dakota, 58103, United States
NCT Number: NCT01214382
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Fargo, North Dakota, 58103, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose sertraline 100 mg, tablet and solution
Other names: Zoloft
Time frame: 72 hour intervals
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 hours
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
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
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
To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels.
North Dakota State University
Other
A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.