This is a study to determine the percentage of patients with depression who are treated with venlafaxine ER 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)...
Date First Received: November 7, 2008
Last Updated: June 9, 2009
Verified by: Wyeth, June 2009
Clinical Trial Phase: Phase 4 | Start Date: September 2008
Overall Status: Recruiting
Estimated Enrollment: 865
Brief Summary
Official Title: “An Open-Label Study to Evaluate the Prevalence of Phenotypic Poor Metabolizers at CYP2D6 Among Venlafaxine-Treated Outpatients With Depression”
Condition Keyword(s):
Intervention(s):
This is a study to determine the percentage of patients with depression who are treated with venlafaxine ER 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).
Study Type: Interventional
Study Design: Health Services Research, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Study Primary Completion Date: August 2009
Intervention(s) in this Clinical Trial
- Procedure: blood draw
Arms, Groups and Cohorts in this Clinical Trial
- Other: 1
Outcome Measures for this Clinical Trial
Primary Measures
- 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
- Time Frame: 1 day
Safety Issue?: No
- Time Frame: 1 day
Secondary Measures
- Determine the percentage of patients treated with venlafaxine ER who are genotypic Poor Metabolizers.
- Time Frame: 1 day
Safety Issue?: No
- Time Frame: 1 day
Criteria for Participation in this Clinical Trial
Main Inclusion Criteria:
- 1. Men and women subjects aged 18 years or older.
- 2. Current outpatient treatment with venlafaxine ER, within the US Food and Drug
- Administration (FDA)-approved dosage range for depression (75 mg/day to 225 mg/day), for up to 8 weeks.
- 3. Ability to have a blood draw within 4 to 12 hours of the most recent dose of venlafaxine ER.
Main Exclusion Criteria:
- 1. Determination by the investigator that a blood draw is contraindicated.
- 2. Participation in an investigational study within the past 30 days where the study medication is not known.
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
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Overall Contact: Trial Manager clintrialparticipation@wyeth.com
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
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