Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT01214382
First received: September 30, 2010
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Roux en Y Gastric Bypass Surgery
Drug: Sertraline
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass

Resource links provided by NLM:


Further study details as provided by North Dakota State University:

Primary Outcome Measures:
  • Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC) [ Time Frame: 72 hour intervals ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Bioavailability comparison between sertraline tablet and sertraline liquid [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.

  • Body Composition and Weight [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Chanes in body compsition and weight will be correlated with changes observed in sertraline pharmacokinetic parameters and will be considered exploratory.

  • Hepatic Function [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    To assess the area under the curve (AUC) ratio of N-desmethylsertraline to sertraline as a measure of hepatic function over time.

  • Plasma Protein Concentrations [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels.


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline Drug: Sertraline
Single dose sertraline 100 mg, tablet and solution
Other Name: Zoloft

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214382

Locations
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
North Dakota State University
Investigators
Principal Investigator: Kristine J Steffen, Pharm.D., Ph.D. Neuropsychiatric Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT01214382     History of Changes
Other Study ID Numbers: 1K23DK085066-01
Study First Received: September 30, 2010
Last Updated: September 26, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by North Dakota State University:
Gastric Bypass
Bariatric Surgery
Sertraline
Zoloft
Pharmacokinetic

Additional relevant MeSH terms:
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014