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Trial record 1 of 1 for:    NCT00788944
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Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00788944
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : January 7, 2011
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Depression Procedure: blood draw Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 971 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression
Study Start Date : October 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
1 Procedure: blood draw
Test Article was not provided to subjects for this study.

Primary Outcome Measures :
  1. 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers. [ Time Frame: 1 day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00788944

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Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00788944    
Other Study ID Numbers: 0600B1-4433
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs