The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
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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 |
| 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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Giselle Hamad, MD | University of Pittsburgh |
More Information
Publications:
| 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 |
| Study First Received: | March 15, 2011 |
| Last Updated: | March 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
pharmacokinetics serotonin reuptake inhibitors gastric bypass depression |
bioavailability drug absorption area under curve |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Mental Disorders Behavioral Symptoms Mood Disorders Serotonin Serotonin Uptake Inhibitors |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013