Status:
COMPLETED
Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels
Lead Sponsor:
Mayo Clinic
Conditions:
Bariatric Surgery
Gastric Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01867255
Start Date
October 1 2013
End Date
March 1 2015
Last Update
December 23 2015
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905