Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl
An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression
2 other identifiers
interventional
971
1 country
52
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 depression
Started Oct 2008
Shorter than P25 for phase_4 depression
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJanuary 7, 2011
January 1, 2011
9 months
November 7, 2008
January 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
1 day
Secondary Outcomes (1)
Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.
1 day
Study Arms (1)
1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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®.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Pfizer Investigational Site
Birmingham, Alabama, 35216, United States
Pfizer Investigational Site
Tuscon, Arizona, 85710, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72223, United States
Pfizer Investigational Site
National City, California, 91950, United States
Pfizer Investigational Site
Oceanside, California, 92056, United States
Pfizer Investigational Site
Santa Ana, California, 92701, United States
Pfizer Investigational Site
Temecula, California, 92591, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80909, United States
Pfizer Investigational Site
Denver, Colorado, 80204, United States
Pfizer Investigational Site
Cromwell, Connecticut, 06416, United States
Pfizer Investigational Site
Milford, Connecticut, 06460, United States
Pfizer Investigational Site
Coral Gables, Florida, 33134, United States
Pfizer Investigational Site
Lauderhill, Florida, 33319, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33409, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Naperville, Illinois, 60563, United States
Pfizer Investigational Site
Wichita, Kansas, 67207, United States
Pfizer Investigational Site
Wichita, Kansas, 67211, United States
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017, United States
Pfizer Investigational Site
Florence, Kentucky, 41042, United States
Pfizer Investigational Site
Columbia, Maryland, 21045, United States
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201, United States
Pfizer Investigational Site
Watertown, Massachusetts, 02472, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49009, United States
Pfizer Investigational Site
Stevensville, Michigan, 49127, United States
Pfizer Investigational Site
Chesterfield, Missouri, 63017, United States
Pfizer Investigational Site
Jefferson City, Missouri, 65109, United States
Pfizer Investigational Site
Kalispell, Montana, 59901, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89119, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87108, United States
Pfizer Investigational Site
Brooklyn, New York, 11223, United States
Pfizer Investigational Site
Brooklyn, New York, 11235, United States
Pfizer Investigational Site
Staten Island, New York, 10312, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28209, United States
Pfizer Investigational Site
Wilmington, North Carolina, 28401, United States
Pfizer Investigational Site
Bismarck, North Dakota, 58051, United States
Pfizer Investigational Site
Fargo, North Dakota, 58104, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45245, United States
Pfizer Investigational Site
Kettering, Ohio, 45429, United States
Pfizer Investigational Site
Mason, Ohio, 45040, United States
Pfizer Investigational Site
Norman, Oklahoma, 73069, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 10213, United States
Pfizer Investigational Site
Bridgeville, Pennsylvania, 15017, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139, United States
Pfizer Investigational Site
Pottstown, Pennsylvania, 19464, United States
Pfizer Investigational Site
Reading, Pennsylvania, 19606, United States
Pfizer Investigational Site
Greenville, South Carolina, 29615, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Bellevue, Washington, 98004, United States
Related Publications (1)
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.
PMID: 23541126DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 11, 2008
Study Start
October 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
January 7, 2011
Record last verified: 2011-01