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

Phase 4

Completed

• Conditions: Depression
• Interventions: Procedure: blood draw

• Registration Number: NCT00788944
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 971

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	blood draw	-

Primary Outcome Measures

Name	Time	Method
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)	1 day

Secondary Outcome Measures

Name	Time	Method
Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.	1 day

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Bellevue, Washington, United States