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

Wyeth

Status and phase

Completed

Phase 4

Conditions

Depression

Treatments

Procedure: blood draw

Study type

Interventional

Funder types

Industry

Identifiers

NCT00788944

B2411001

0600B1-4433

Details and patient eligibility

About

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).

Enrollment

971 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.