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

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867255
• Other study ID #: 12-005860
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2013
• Last updated: December 21, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Gastric Bypass
• Roux-en-Y Gastric Bypass

Intervention

Drug:
• venlafaxine ER (extended-release) 75 mg
A single dose of venlafaxine ER 75 mg is to be administered once at each of two study visits, pre- and post-gastric bypass surgery.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venlafaxine levels pre- and post-gastric bypass	This study will measure and compare venlafaxine and desvenlafaxine levels in participants before, and again 3 to 4 months after, gastric bypass surgery.	3 to 4 months	No