Status:
COMPLETED
Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
971 Patients enrolled
Trial Details
Trial ID
NCT00788944
Start Date
October 1 2008
End Date
July 1 2009
Last Update
January 7 2011
Active Locations (52)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
2
Pfizer Investigational Site
Tuscon, Arizona, United States, 85710
3
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72223
4
Pfizer Investigational Site
National City, California, United States, 91950