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

This study has been completed.
Sponsor:
Collaborator:
University of North Dakota
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT01015976
First received: October 1, 2009
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Procedure: bariatric surgery
Other: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects

Resource links provided by NLM:


Further study details as provided by Neuropsychiatric Research Institute, Fargo, North Dakota:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    AUC of surgery group compared to the AUC of control group


Enrollment: 10
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post bariatric surgery
Roux en Y bariatric surgery
Procedure: bariatric surgery
Roux en Y bariatric surgery
Control
No surgery
Other: control
No surgery

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01015976

Locations
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Neuropsychiatric Research Institute, Fargo, North Dakota
University of North Dakota
Investigators
Principal Investigator: James Roerig, PharmD, BCPP Neuropsychiatric Research Institute and University of North Dakota
  More Information

Additional Information:
No publications provided

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01015976     History of Changes
Other Study ID Numbers: 200803-272
Study First Received: October 1, 2009
Results First Received: October 28, 2013
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Gastric Bypass
Sertraline
Pharmacokinetics

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014