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

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ClinicalTrials.gov Identifier: NCT01317147
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Gastric Bypass Depression Anxiety Disorder 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.

Study Design

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
Study Start Date : August 2007
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Serotonin
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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.

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

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

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 Posted: March 17, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
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