Depression
Conditions
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).
Interventions
PROCEDUREblood draw
Test Article was not provided to subjects for this study.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood) | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers. | 1 day |
Countries
United States
Outcome results
None listed