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Completed

NCT Number: NCT00788944

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

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draw

Procedure

Test Article was not provided to subjects for this study.

Primary outcomes

  1. 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)

    Time frame: 1 day

Secondary outcomes

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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2008
Registry last updated
Jan 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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