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

NCT01867255 | Completed Phase 1

• 1 other identifier: 12-005860
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

venlafaxine; Effexor; antidepressive agent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

venlafaxine ER

OTHER

venlafaxine ER (extended-release) 75 mg once

Drug: venlafaxine ER (extended-release) 75 mg

Interventions

venlafaxine ER (extended-release) 75 mg DRUG

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.

Also known as: Effexor XR 75 mg

venlafaxine ER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Approved to undergo Roux-en-Y gastric bypass surgery (cost of surgery is NOT included in the study)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Carrie Krieger, PharmD, RPh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, BCACP

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

US (1)