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

NCT ID: NCT01015976

Last Updated: 2014-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Keywords

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Gastric Bypass Sertraline Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Post bariatric surgery

Roux en Y bariatric surgery

Group Type EXPERIMENTAL

bariatric surgery

Intervention Type PROCEDURE

Roux en Y bariatric surgery

Control

No surgery

Group Type OTHER

control

Intervention Type OTHER

No surgery

Interventions

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bariatric surgery

Roux en Y bariatric surgery

Intervention Type PROCEDURE

control

No surgery

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Dakota

OTHER

Sponsor Role collaborator

Neuropsychiatric Research Institute, Fargo, North Dakota

OTHER

Sponsor Role lead

Responsible Party

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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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Roerig, PharmD, BCPP

Role: PRINCIPAL_INVESTIGATOR

Neuropsychiatric Research Institute and University of North Dakota

Locations

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Neuropsychiatric Research Institute

Fargo, North Dakota, United States

Site Status

Countries

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United States

Related Links

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http://www.nrifargo.com/

Neuropsychiatric Research Institute

Other Identifiers

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200803-272

Identifier Type: -

Identifier Source: org_study_id