Obesity
Conditions
Keywords
Gastric Bypass, Sertraline, Pharmacokinetics
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.
Interventions
PROCEDUREbariatric surgery
Roux en Y bariatric surgery
OTHERcontrol
No surgery
Sponsors
University of North Dakota
Neuropsychiatric Research Institute, Fargo, North Dakota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC Post Surgery (n =5) Compared to AUC Control (n=5) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Drug Single arm study, all receive active drug
Sertraline : Single dose of 100mg sertraline | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Active Drug |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 46.6 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
AUC Post Surgery (n =5) Compared to AUC Control (n=5)
AUC of surgery group compared to the AUC of control group
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
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | AUC Post Surgery (n =5) Compared to AUC Control (n=5) | Post surgery | 124.4 ng-hr/mL | Standard Deviation 55.5 |
| Control | AUC Post Surgery (n =5) Compared to AUC Control (n=5) | Control | 314.8 ng-hr/mL | Standard Deviation 129.6 |