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Completed

NCT Number: NCT01214382

Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
  • 2. Hypersensitivity to sertraline or any excipient contained in either the tablet or solution
  • 3. Inability to tolerate blood draws
  • 4. 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
  • 5. Alcohol or other substance abuse in the past four weeks or dependence in the past year
  • 6. Currently pregnant or lactating or any participant who wants to become pregnant during the study
  • 7. Female participant unwilling to use an accepted method of birth control during the study assessment periods.
  • 8. 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
  • 9. Inability or unwillingness to avoid alcohol or grapefruit juice for the required study duration
  • 10. 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.
  • 11. Medical condition which may increase participant risk with sertraline
  • 12. 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.)
  • 13. History of daily tobacco product use in the past six months
  • 14. Participants who have undergone any type of prior surgical procedure for weight loss
  • 15. Significant Latex allergy (liquid form has a latex dropper)
  • 16. Participant employed by, or who has immediate family employed by NRI
  • 17. History of Hepatitis or HIV Infection

Treatment and study plan

Sertraline

Drug

Single dose sertraline 100 mg, tablet and solution

Other names: Zoloft

Primary outcomes

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

    Time frame: 72 hour intervals

    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.

Secondary outcomes

  1. Bioavailability comparison between sertraline tablet and sertraline liquid

    Time frame: 72 hours

    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.

  2. Body Composition and Weight

    Time frame: 72 hours

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

  3. Hepatic Function

    Time frame: 72 hours

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

  4. Plasma Protein Concentrations

    Time frame: 72 hours

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

Sponsors and collaborators

Lead sponsor

North Dakota State University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2010
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.