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

Pharmacokinetic Study Comparing Area Under the Curve for a Single Dose of Venlafaxine ER Pre- and Post-gastric Bypass

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01867255

Enrollment

Registered

2013-06-03

Start date

2013-10-31

Completion date

2015-03-31

Last updated

2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Gastric Bypass, Roux-en-Y Gastric Bypass

Keywords

venlafaxine, Effexor, antidepressive agent

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.

Interventions

DRUGvenlafaxine ER (extended-release) 75 mg

A single dose of venlafaxine ER 75 mg is to be administered once at each of two study visits, pre- and post-gastric bypass surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Approved to undergo Roux-en-Y gastric bypass surgery (cost of surgery is NOT included in the study)

Exclusion criteria

* Pregnant * Allergy to venlafaxine or desvenlafaxine * Psychiatric hospitalization within the prior 12 months * Active professional treatment for recent substance abuse within 12 months of abstinence * Ongoing psychologic issues, such as personality disorders, difficulties as a trauma survivor, or difficulties with depression unless a stable, documented course of treatment by a licensed mental health professional is available * Current use of any of the following medications/supplements: 5-hydroxytryptophan, almotriptan, amitriptyline, amoxapine, amoxicillin-clavulanate, amphetamine-dextroamphetamine, atazanavir, bupropion, cinacalcet, citalopram, clarithromycin, clomipramine, desipramine, desvenlafaxine, dextroamphetamine, dextromethorphan, doxepin, duloxetine, eletriptan, entacapone, escitalopram, fluoxetine, fluvoxamine, frovatriptan, haloperidol, imipramine, isocarboxazid, itraconazole, jujube seed extract, linezolid, maprotiline, methylene blue, metoclopramide, metoprolol, milnacipran, mirtazapine, naratriptan, nefazodone, nelfinavir, nortriptyline, paroxetine, phenelzine, procarbazine, protriptyline, quinidine, rasagiline, ritonavir, rizatriptan, saquinavir, selegiline, sertraline, St. John's wort, sumatriptan, tapentadol, terbinafine, toremifene, tramadol, tranylcypromine, trazodone, trifluoperazine, trimipramine, tryptophan, L-tryptophan, venlafaxine, vilazodone, zolmitriptan

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026