The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

March 15, 2011 updated by: University of Pittsburgh
The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively. Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies (PK) preoperatively. Maximum concentration (CMAX), time to CMAX (TMAX), and Area Under Concentration/Time curve (AUC) were determined. PK studies were repeated at one, six, and twelve months post-operatively. PK data were corrected for dose at each study time point. The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Bariatric surgery clinic- Morbidly obese patients seeking RYGB who met criteria for bariatric surgery (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with severe obesity-related comorbidities) and were received maintenance treatment with an SRI for primary mood or anxiety disorder.

Description

Inclusion Criteria:

  • Able to tolerate general anesthesia
  • Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months
  • Able to provide informed consent
  • Cleared for surgery by primary care MD, dietician, and psychiatrist
  • SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks

Exclusion Criteria:

  • pregnancy
  • Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric bypass patients
Procedure: Roux-en-Y gastric bypass (RYGBP)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

American Society for Metabolic and Bariatric Surgery

Investigators

  • Principal Investigator: Giselle Hamad, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07120162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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