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

Official Title: “A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects”

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.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • Single dose of 100mg sertraline

Primary Measures

• 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 BMI,age and gender.
  • Time Frame: At Study Visit
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Neuropsychiatric Research Institute, Fargo, North Dakota Other

Overall Clinical Trial Officials and Contacts

James Roerig, PharmD, BCPP Principal Investigator Neuropsychiatric Research Institute and University of North Dakota  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01015976

Study ID Number: 200803-272

ClinicalTrials.gov Identifier: NCT01015976

Health Authority: United States: Institutional Review Board

Neuropsychiatric Research Institute