A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
This study has been completed.
University of North Dakota
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
First received: October 1, 2009
Last updated: May 1, 2013
Last verified: May 2013
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.
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
Primary Outcome 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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2010 (Final data collection date for primary outcome measure)
Experimental: Active drug
Single arm study, all receive active drug
Single dose of 100mg sertraline
Other Name: Zoloft
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.
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015976
|Neuropsychiatric Research Institute
|Fargo, North Dakota, United States, 58103 |
Neuropsychiatric Research Institute, Fargo, North Dakota
University of North Dakota
||James Roerig, PharmD, BCPP
||Neuropsychiatric Research Institute and University of North Dakota
No publications provided
||James Roerig, James L. Roerig, Pharm.D., BCPP, University of North Dakota Department of Clinical Neuroscience, Grand Forks, ND and the Neuropsychiatric Research Institute, Fargo, ND., Neuropsychiatric Research Institute, Fargo, North Dakota
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 1, 2009
||May 1, 2013
||United States: Institutional Review Board
Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Signs and Symptoms
Central Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs