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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bariatric Surgery; Gastric Bypass; Roux-en-Y Gastric Bypass

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

Phase: N/A

Status: Active, not recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Carrie Krieger, PharmD, RPh, Principal Investigator, Affiliation: Mayo Clinic

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Venlafaxine levels pre- and post-gastric bypass

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States
Additional Information

Starting date: October 2013
Last updated: April 9, 2015

Page last updated: August 23, 2015

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