A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
This study has been completed.
Sponsor:
Neuropsychiatric Research Institute, Fargo, North Dakota
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: May 1, 2013
Last verified: May 2013
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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 |
Drug: Sertraline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group 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:
- 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 ]
| 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: Active drug
Single arm study, all receive active drug
|
Drug: Sertraline
Single dose of 100mg sertraline
Other Name: Zoloft
|
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
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 |
| Last Updated: | May 1, 2013 |
| 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 Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013