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

Completed · Phase 4

Conditions studied: Depression

In brief

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).

Key facts

Study ID

NCT00788944

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

971

Starts

2008-10-01

Expected to finish

2009-07-01

Last updated by the study team

2011-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Pfizer Investigational Site — Tuscon, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — National City, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Temecula, California, United States
• Pfizer Investigational Site — Colorado Springs, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Cromwell, Connecticut, United States
• Pfizer Investigational Site — Milford, Connecticut, United States
• Pfizer Investigational Site — Coral Gables, Florida, United States
• Pfizer Investigational Site — Lauderhill, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Naperville, Illinois, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Crestview Hills, Kentucky, United States
• Pfizer Investigational Site — Florence, Kentucky, United States
• Pfizer Investigational Site — Columbia, Maryland, United States
• Pfizer Investigational Site — Pittsfield, Massachusetts, United States
• Pfizer Investigational Site — Watertown, Massachusetts, United States
• Pfizer Investigational Site — Kalamazoo, Michigan, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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