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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317147
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Society for Metabolic and Bariatric Surgery
Information provided by:
University of Pittsburgh
  Purpose
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.

Condition Intervention
Gastric Bypass Depression Anxiety Disorder Procedure: Roux-en-Y gastric bypass (RYGBP)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Enrollment: 12
Study Start Date: August 2007
Study Completion Date: August 2010
Groups/Cohorts Assigned Interventions
Gastric bypass patients Procedure: Roux-en-Y gastric bypass (RYGBP)

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317147


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
American Society for Metabolic and Bariatric Surgery
Investigators
Principal Investigator: Giselle Hamad, MD University of Pittsburgh
  More Information

Publications:
First MB, Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for DSM-IV axis I disorders—patient edition. : New York State Psychiatric Institute; 1996.
Williams JBW, Terman M. Structured Interview Guide for the Hamilton Depression Rating Scale with Ayptical Depression Supplement (SIGH-ADS). New York: New York State Psychiatric Institute; 2003.

Responsible Party: Giselle Hamad, MD Assistant Professor of Surgery, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT01317147     History of Changes
Other Study ID Numbers: PRO07120162
First Submitted: March 15, 2011
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
Last Verified: March 2011

Keywords provided by University of Pittsburgh:
pharmacokinetics
serotonin reuptake inhibitors
gastric bypass
depression
bioavailability
drug absorption
area under curve

Additional relevant MeSH terms:
Depression
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Serotonin
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators