Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01015976
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Sponsor:
Collaborator:
University of North Dakota
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Procedure: bariatric surgery Other: control Phase 3

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Post bariatric surgery
Roux en Y bariatric surgery
 Procedure: bariatric surgery
Roux en Y bariatric surgery
Control
No surgery
 Other: control
No surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015976


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: James Roerig, PharmD, BCPP Neuropsychiatric Research Institute and University of North Dakota
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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    
Other Study ID Numbers: 200803-272
First Posted: November 18, 2009    Key Record Dates
Results First Posted: March 31, 2014
Last Update Posted: March 31, 2014
Last Verified: February 2014
Keywords provided by James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota:
Gastric Bypass
Sertraline
Pharmacokinetics