Clinical trial NCT01015976: A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
Official title: A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Gastric Bypass
Sertraline
Pharmacokinetics
Lead sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
Sponsor class: OTHER
Collaborators: name: University of North Dakota
First posted: 2009-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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 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.

Primary outcomes:
measure: AUC Post Surgery (n =5) Compared to AUC Control (n=5)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute
state: North Dakota
Study officials:
affiliation: Neuropsychiatric Research Institute and University of North Dakota
name: James Roerig, PharmD, BCPP
role: PRINCIPAL_INVESTIGATOR
References: