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

Completed

• Conditions: Gastric Bypass; Depression; Anxiety Disorder
• Interventions: Procedure: Roux-en-Y gastric bypass (RYGBP)

• Registration Number: NCT01317147
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study Start: 2007-08
• Study Completion: 2010-08
• Status Verified: 2011-03
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Last Update Submitted: 2011-03-15
• Study First Posted: 2011-03-17
• Last Update Posted: 2011-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric bypass patients	Roux-en-Y gastric bypass (RYGBP)	-

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States