Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00788944
Collaborator
(none)
971
53
1
9
18.3
2
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
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
:
Oct 1, 2008
Actual Primary Completion Date
:
Jul 1, 2009
Actual Study Completion Date
:
Jul 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1
|
Procedure: blood draw
Test Article was not provided to subjects for this study.
|
Outcome Measures
Primary Outcome Measures
- 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood) [1 day]
Secondary Outcome Measures
- Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers. [1 day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35216 |
| 2 | Pfizer Investigational Site | Tuscon | Arizona | United States | 85710 |
| 3 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72223 |
| 4 | Pfizer Investigational Site | National City | California | United States | 91950 |
| 5 | Pfizer Investigational Site | Ocean Side | California | United States | 92056 |
| 6 | Pfizer Investigational Site | Oceanside | California | United States | 92056 |
| 7 | Pfizer Investigational Site | Santa Ana | California | United States | 92701 |
| 8 | Pfizer Investigational Site | Temecula | California | United States | 92591 |
| 9 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80909 |
| 10 | Pfizer Investigational Site | Denver | Colorado | United States | 80204 |
| 11 | Pfizer Investigational Site | Cromwell | Connecticut | United States | 06416 |
| 12 | Pfizer Investigational Site | Milford | Connecticut | United States | 06460 |
| 13 | Pfizer Investigational Site | Coral Gables | Florida | United States | 33134 |
| 14 | Pfizer Investigational Site | Lauderhill | Florida | United States | 33319 |
| 15 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 16 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33409 |
| 17 | Pfizer Investigational Site | Decatur | Georgia | United States | 30033 |
| 18 | Pfizer Investigational Site | Naperville | Illinois | United States | 60563 |
| 19 | Pfizer Investigational Site | Wichita | Kansas | United States | 67207 |
| 20 | Pfizer Investigational Site | Wichita | Kansas | United States | 67211 |
| 21 | Pfizer Investigational Site | Crestview Hills | Kentucky | United States | 41017 |
| 22 | Pfizer Investigational Site | Florence | Kentucky | United States | 41042 |
| 23 | Pfizer Investigational Site | Columbia | Maryland | United States | 21045 |
| 24 | Pfizer Investigational Site | Pittsfield | Massachusetts | United States | 01201 |
| 25 | Pfizer Investigational Site | Watertown | Massachusetts | United States | 02472 |
| 26 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | 49009 |
| 27 | Pfizer Investigational Site | Stevensville | Michigan | United States | 49127 |
| 28 | Pfizer Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 29 | Pfizer Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 30 | Pfizer Investigational Site | Kalispell | Montana | United States | 59901 |
| 31 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89119 |
| 32 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87108 |
| 33 | Pfizer Investigational Site | Brooklyn | New York | United States | 11223 |
| 34 | Pfizer Investigational Site | Brooklyn | New York | United States | 11235 |
| 35 | Pfizer Investigational Site | Staten Island | New York | United States | 10312 |
| 36 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28209 |
| 37 | Pfizer Investigational Site | Wilmington | North Carolina | United States | 28401 |
| 38 | Pfizer Investigational Site | Bismarck | North Dakota | United States | 58051 |
| 39 | Pfizer Investigational Site | Fargo | North Dakota | United States | 58104 |
| 40 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45245 |
| 41 | Pfizer Investigational Site | Kettering | Ohio | United States | 45429 |
| 42 | Pfizer Investigational Site | Mason | Ohio | United States | 45040 |
| 43 | Pfizer Investigational Site | Norman | Oklahoma | United States | 73069 |
| 44 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 10213 |
| 45 | Pfizer Investigational Site | Bridgeville | Pennsylvania | United States | 15017 |
| 46 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19139 |
| 47 | Pfizer Investigational Site | Pottstown | Pennsylvania | United States | 19464 |
| 48 | Pfizer Investigational Site | Reading | Pennsylvania | United States | 19606 |
| 49 | Pfizer Investigational Site | Greenville | South Carolina | United States | 29615 |
| 50 | Pfizer Investigational Site | Mt. Pleasant | South Carolina | United States | 29464 |
| 51 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38119 |
| 52 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 53 | Pfizer Investigational Site | Bellevue | Washington | United States | 98004 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00788944
Other Study ID Numbers:
- 0600B1-4433
- B2411001
First Posted:
Nov 11, 2008
Last Update Posted:
Jan 7, 2011
Last Verified:
Jan 1, 2011
Additional relevant MeSH terms: