A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects

Neuropsychiatric Research Institute, Fargo, North Dakota10 enrolled

Overview

The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.

Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

bariatric surgeryPROCEDURE

Roux en Y bariatric surgery

controlOTHER

No surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects between the ages of 18 and 60 years. * Subjects must be of good general health by history and physical exam. * Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement. * Five subjects matched for body mass index, age and sex to the post bariatric surgery group. * No contraindications to receiving a single dose of 100 mg of sertraline. * Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraception) and have a negative pregnancy test at baseline. Exclusion Criteria: * Allergy to sertraline or any of its constituents. * Candidates currently receiving sertraline or any other antidepressant. * Candidates currently receiving a medication that interacts with sertraline (Zoloft) * Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes. * Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease. * Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder. * Candidates who have participated in an investigational drug study in past 30 days. * Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency. * Candidates who are pregnant or nursing at time of study.

Locations (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

AUC Post Surgery (n =5) Compared to AUC Control (n=5)

AUC of surgery group compared to the AUC of control group

Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours

Data from ClinicalTrials.gov

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