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

Completed · Phase 1

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

In brief

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.

Key facts

Study ID

NCT01867255

Run by

Mayo Clinic

People needed

10

Starts

2013-10-01

Expected to finish

2015-03-01

Last updated by the study team

2015-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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