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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: venlafaxine ER (extended-release) 75 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: venlafaxine ER<br>venlafaxine ER (extended-release) 75 mg once | Drug: venlafaxine ER (extended-release) 75 mg<br>* 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.<br>* Other names: Effexor XR 75 mg;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venlafaxine, Effexor, antidepressive agent