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CompletedNCT01214382Updated Apr 6, 2016

Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery

A Phase 3 interventional study of Sertraline in Roux en Y Gastric Bypass Surgery, sponsored by North Dakota State University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by North Dakota State University · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study summary

This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.

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Conditions studied

  • Roux en Y Gastric Bypass Surgery

Keywords

  • Gastric Bypass
  • Bariatric Surgery
  • Sertraline
  • Zoloft
  • Pharmacokinetic
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In context

Lead sponsor

North Dakota State University is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Male or female between 18 and 60 years of age at the time of Informed Consent
    1. Scheduled to undergo Roux en Y Gastric Bypass Surgery (RYGBP) or in evaluation for surgery prior to scheduling at the investigators' discretion.
    1. Ability to swallow whole medication tablets and eat solid foods

Exclusion criteria

Exclusion Criteria:

    1. Those taking any medication at the time of the study which has a known, clinically significant, drug-interaction with sertraline, which may affect participant safety or threaten the validity of the data.
    1. Hypersensitivity to sertraline or any excipient contained in either the tablet or solution
    1. Inability to tolerate blood draws
    1. History of or current bipolar disorder, psychotic disorder, or current major depressive disorder or suicidality, or other psychiatric condition that the investigator feels may put the subject at additional risk by participating in the study
    1. Alcohol or other substance abuse in the past four weeks or dependence in the past year
    1. Currently pregnant or lactating or any participant who wants to become pregnant during the study
    1. Female participant unwilling to use an accepted method of birth control during the study assessment periods.
    1. Disulfiram or metronidazole at baseline (due to small percentage of alcohol in sertraline solution) or other medication with a similar interaction with a very small amount of alcohol
    1. Inability or unwillingness to avoid alcohol or grapefruit juice for the required study duration
    1. Baseline medications which significantly alter gastrointestinal transit time (e.g. oral anticholinergic medications, metoclopramide, erythromycin) and are taken on a routinely scheduled basis. In addition, any such medication cannot be taken in close proximity (minimum of five half-lives of the drug) to the study sertraline administration.
    1. Medical condition which may increase participant risk with sertraline
    1. Hepatic insufficiency (Hepatic insufficiency will be defined as any liver enzyme test on a standard hepatic panel of greater than or equal to twice the upper limit of normal, or any other hepatic abnormality identified on physical exam, self-report, or laboratory testing that puts the participant at risk in the opinion of the study physician or physician assistant.)
    1. History of daily tobacco product use in the past six months
    1. Participants who have undergone any type of prior surgical procedure for weight loss
    1. Significant Latex allergy (liquid form has a latex dropper)
    1. Participant employed by, or who has immediate family employed by NRI
    1. History of Hepatitis or HIV Infection
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Study design

Phase
Phase 3
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Sertraline

    Drug: Sertraline

Interventions

  • DrugSertraline

    Single dose sertraline 100 mg, tablet and solution

    Also known as: Zoloft

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What researchers measure

Primary outcomes

  1. Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC)

    The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.

    Time frame: 72 hour intervals

Secondary outcomes

  1. Bioavailability comparison between sertraline tablet and sertraline liquid

    To characterize the relative bioavailability of the tablet formulation of sertraline 100mg as compared to a reference dose of the liquid preparation of sertraline 100mg before and at three and 12 months following RYGBP.

    Time frame: 72 hours

  2. Body Composition and Weight

    Chanes in body compsition and weight will be correlated with changes observed in sertraline pharmacokinetic parameters and will be considered exploratory.

    Time frame: 72 hours

  3. Hepatic Function

    To assess the area under the curve (AUC) ratio of N-desmethylsertraline to sertraline as a measure of hepatic function over time.

    Time frame: 72 hours

  4. Plasma Protein Concentrations

    To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels.

    Time frame: 72 hours

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Study locations

1 site
  • Neuropsychiatric Research Institute
    Fargo, North Dakota 58103, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01214382
Lead sponsor
North Dakota State University
Collaborators
National Institutes of Health (NIH)
Responsible party
Kristine Steffen (Associate Professor, North Dakota State University, Neuropsychiatric Research Institute, Fargo, North Dakota) — Principal investigator
First posted
Oct 5, 2010
Start date
Oct 2010
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Apr 6, 2016

Study contacts

Kristine J Steffen, Pharm.D., Ph.D.
principal investigator · Neuropsychiatric Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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