Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels

Phase 1

Completed

• Conditions: Gastric Bypass; Roux-en-Y Gastric Bypass; Bariatric Surgery
• Interventions: Drug: venlafaxine ER (extended-release) 75 mg

• Registration Number: NCT01867255
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of the study is to determine whether a significant and predictable change in bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-03
• Study Start: 2013-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
venlafaxine ER	venlafaxine ER (extended-release) 75 mg	venlafaxine ER (extended-release) 75 mg once

Primary Outcome Measures

Name	Time	Method
Venlafaxine levels pre- and post-gastric bypass	3 to 4 months	This study will measure and compare venlafaxine and desvenlafaxine levels in participants before, and again 3 to 4 months after, gastric bypass surgery.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States