Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl

NCT ID: NCT00788944

Last Updated: 2011-01-07

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

PHASE4

Total Enrollment

971 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-07-31

Brief Summary

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This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

blood draw

Intervention Type PROCEDURE

Test Article was not provided to subjects for this study.

Interventions

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blood draw

Test Article was not provided to subjects for this study.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men and women subjects aged 18 years or older.
* Current outpatient treatment with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37.5 mg/day to 225 mg/day), for 8 weeks or less.
* Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor XR®.

Exclusion Criteria

* Determination by the investigator that a blood draw is contraindicated.
* Participation in an investigational study within the past 30 days where the study medication is not known.
* Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in the 6 months prior to current treatment regimen.
* Treatment with DVS SR within the last 30 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Tuscon, Arizona, United States

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Little Rock, Arkansas, United States

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National City, California, United States

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Oceanside, California, United States

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Santa Ana, California, United States

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Temecula, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Cromwell, Connecticut, United States

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Milford, Connecticut, United States

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Coral Gables, Florida, United States

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Lauderhill, Florida, United States

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West Palm Beach, Florida, United States

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West Palm Beach, Florida, United States

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Decatur, Georgia, United States

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Naperville, Illinois, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Crestview Hills, Kentucky, United States

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Florence, Kentucky, United States

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Columbia, Maryland, United States

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Pittsfield, Massachusetts, United States

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Watertown, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Stevensville, Michigan, United States

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Chesterfield, Missouri, United States

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Jefferson City, Missouri, United States

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Kalispell, Montana, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Wilmington, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Kettering, Ohio, United States

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Mason, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Bridgeville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Greenville, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Memphis, Tennessee, United States

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San Antonio, Texas, United States

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Bellevue, Washington, United States

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Countries

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United States

References

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Preskorn SH, Kane CP, Lobello K, Nichols AI, Fayyad R, Buckley G, Focht K, Guico-Pabia CJ. Cytochrome P450 2D6 phenoconversion is common in patients being treated for depression: implications for personalized medicine. J Clin Psychiatry. 2013 Jun;74(6):614-21. doi: 10.4088/JCP.12m07807. Epub 2013 Mar 13.

Reference Type DERIVED
PMID: 23541126 (View on PubMed)

Related Links

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Other Identifiers

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B2411001

Identifier Type: -

Identifier Source: secondary_id

0600B1-4433

Identifier Type: -

Identifier Source: org_study_id

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