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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:March 2015

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

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.


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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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