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

NCT ID: NCT01867255

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Gastric Bypass Roux-en-Y Gastric Bypass

Keywords

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venlafaxine Effexor antidepressive agent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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venlafaxine ER

venlafaxine ER (extended-release) 75 mg once

Group Type OTHER

venlafaxine ER (extended-release) 75 mg

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Effexor XR 75 mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Carrie A. Krieger

PharmD, BCACP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carrie Krieger, PharmD, RPh

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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12-005860

Identifier Type: -

Identifier Source: org_study_id