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Completed

NCT Number: NCT01015976

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

Roux en Y bariatric surgery

Control

Other

No surgery

Primary outcomes

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

    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

    AUC of surgery group compared to the AUC of control group

Sponsors and collaborators

Lead sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

Other

Collaborators

  • University of North Dakota

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2009
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

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