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

Official Title: “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).

Intervention(s) in this Clinical Trial

• Procedure: blood draw
  • Test Article was not provided to subjects for this study.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
  • Time Frame: 1 day
    Safety Issue?: No

Secondary Measures

• Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.
  • Time Frame: 1 day
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00788944

Study ID Number: 0600B1-4433

ClinicalTrials.gov Identifier: NCT00788944

Health Authority: United States: Institutional Review Board

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