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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Gastric Bypass; Bariatric Surgery; Roux-en-Y Gastric Bypass

Treatments: Drug: venlafaxine ER (extended-release) 75 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01867255

12-005860

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

venlafaxine ER

Other group

Description:

venlafaxine ER (extended-release) 75 mg once

Treatment:

Drug: venlafaxine ER (extended-release) 75 mg