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
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