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

Completed · Phase 3

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT01015976

Run by

Neuropsychiatric Research Institute, Fargo, North Dakota

People needed

10

Starts

2009-02-01

Expected to finish

2010-04-01

Last updated by the study team

2014-03-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neuropsychiatric Research Institute — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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