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

January 5, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

971

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Pfizer Investigational Site
    • Arizona
      • Tuscon, Arizona, United States, 85710
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • Pfizer Investigational Site
    • California
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • Ocean Side, California, United States, 92056
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92701
        • Pfizer Investigational Site
      • Temecula, California, United States, 92591
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Pfizer Investigational Site
      • Milford, Connecticut, United States, 06460
        • Pfizer Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Pfizer Investigational Site
      • Lauderhill, Florida, United States, 33319
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Pfizer Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67211
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Florence, Kentucky, United States, 41042
        • Pfizer Investigational Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Pfizer Investigational Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Pfizer Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
      • Stevensville, Michigan, United States, 49127
        • Pfizer Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pfizer Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
    • Montana
      • Kalispell, Montana, United States, 59901
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Pfizer Investigational Site
      • Brooklyn, New York, United States, 11223
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10312
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58051
        • Pfizer Investigational Site
      • Fargo, North Dakota, United States, 58104
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Pfizer Investigational Site
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
      • Mason, Ohio, United States, 45040
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 10213
        • Pfizer Investigational Site
    • Pennsylvania
      • Bridgeville, Pennsylvania, United States, 15017
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19139
        • Pfizer Investigational Site
      • Pottstown, Pennsylvania, United States, 19464
        • Pfizer Investigational Site
      • Reading, Pennsylvania, United States, 19606
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Procedure: blood draw
Test Article was not provided to subjects for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0600B1-4433
  • B2411001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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