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

NCT00788944

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35216, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

DepressionStudy Evaluating Effexor XR in Elderly Patients With Major Depression. NCT00225485
  1. Ichikawa, Chiba
  2. Ichikawa, Chiba
  3. Kasuga, Fukuoka
  4. Kitakyushu, Fukuoka
  5. Ohnojo, Fukuoka
  6. Otaru, Hokkaido
  7. Sapporo, Hokkaido
  8. Sapporo, Hokkaido
  9. Sapporo, Hokkaido
  10. Sapporo, Hokkaido
  11. Sapporo, Hokkaido
  12. Sapporo, Hokkaido
  13. Sapporo, Hokkaido
  14. Sapporo, Hokkaido
  15. Sapporo, Hokkaido
  16. Tsukuba, Ibaragi
  17. Hanamaki, Iwate
  18. Kawasaki, Kanagawa
  19. Kawasaki, Kanagawa
  20. Sagamihara, Kanagawa
  21. Yokohama, Kanagawa
  22. Yokohama, Kanagawa
  23. Moriguchi, Osaka
  24. Osakasayama, Osaka
  25. Osakasayama, Osaka
  26. Sakai, Osaka
  27. Adachi-ku, Tokyo
  28. Chiyoda-ku, Tokyo
  29. Fuchu, Tokyo
  30. Higashimurayama, Tokyo
  31. Kodaira, Tokyo
  32. Meguro-ku, Tokyo
  33. Nakano-ku, Tokyo
  34. Setagaya-ku, Tokyo
  35. Tachikawa, Tokyo
  36. Hiroshima,
  37. Okayama,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
DepressionStudy Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects NCT00329147
  1. Neptune, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
DepressionStudy Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression. NCT00225524
  1. Nagoya, Aichi
  2. Nagoya, Aichi
  3. Ichikawa, Chiba
  4. Ichikawa, Chiba
  5. Kasuga, Fukuoka
  6. Kitakyushu, Fukuoka
  7. Kitakyushu, Fukuoka
  8. Kitakyushu, Fukuoka
  9. Kurume, Fukuoka
  10. Ohnojyo, Fukuoka
  11. Kure, Hiroshima
  12. Otaru, Hokkaido
  13. Sapporo, Hokkaido
  14. Sapporo, Hokkaido
  15. Sapporo, Hokkaido
  16. Sapporo, Hokkaido
  17. Sapporo, Hokkaido
  18. Sapporo, Hokkaido
  19. Nishinomiya, Hyogo
  20. Tsuchiura, Ibaragi
  21. Tsukuba, Ibaragi
  22. Kanazawa, Ishikawa
  23. Hanamaki, Iwate
  24. Kawasaki, Kanagawa
  25. Kawasaki, Kanagawa
  26. Sagamihara, Kanagawa
  27. Sagamihara, Kanagawa
  28. Yokohama, Kanagawa
  29. Yokohama, Kanagawa
  30. Yokohama, Kanagawa
  31. Yokohama, Kanagawa
  32. Yokohama, Kanagawa
  33. Yokohama, Kanagawa
  34. Yokosuka, Kanagawa
  35. Kikuchi, Kumamoto
  36. Ohmura, Nagasaki
  37. Kashihara, Nara
  38. Jyo-etsu, Niigata
  39. Beppu, Ohita
  40. Moriguchi, Osaka
  41. Osakasayama, Osaka
  42. Osakasayama, Osaka
  43. Hamamatsu, Shizuoka
  44. Adachi-ku, Tokyo
  45. Bunkyo-ku, Tokyo
  46. Bunkyo-ku, Tokyo
  47. Chiyoda-ku, Tokyo
  48. Chiyoda-ku, Tokyo
  49. Itabashi-ku, Tokyo
  50. Kodaira, Tokyo
  51. Meguro-ku, Tokyo
  52. Meguro-ku, Tokyo
  53. Meguro-ku, Tokyo
  54. Minato-ku, Tokyo
  55. Minato-ku, Tokyo
  56. Nakano-ku, Tokyo
  57. Ohta-ku, Tokyo
  58. Setagaya-ku, Tokyo
  59. Shinjuku, Tokyo
  60. Tachikawa, Tokyo
  61. Toshima-ku, Tokyo
  62. Toshima-ku, Tokyo
  63. Fukuoka,
  64. Fukuoka,
  65. Fukuoka,
  66. Fukuoka,
  67. Hiroshima,
  68. Hiroshima,
  69. Hiroshima,
  70. Nagasaki,
  71. Osaka,
  72. Osaka,
  73. Saitama,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
DepressionDetermine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl NCT00788944
  1. Birmingham, Alabama
  2. Tuscon, Arizona
  3. Little Rock, Arkansas
  4. National City, California
  5. Ocean Side, California
  6. Oceanside, California
  7. Santa Ana, California
  8. Temecula, California
  9. Colorado Springs, Colorado
  10. Denver, Colorado
  11. Cromwell, Connecticut
  12. Milford, Connecticut
  13. Coral Gables, Florida
  14. Lauderhill, Florida
  15. West Palm Beach, Florida
  16. West Palm Beach, Florida
  17. Decatur, Georgia
  18. Naperville, Illinois
  19. Wichita, Kansas
  20. Wichita, Kansas
  21. Crestview Hills, Kentucky
  22. Florence, Kentucky
  23. Columbia, Maryland
  24. Pittsfield, Massachusetts
  25. Watertown, Massachusetts
  26. Kalamazoo, Michigan
  27. Stevensville, Michigan
  28. Chesterfield, Missouri
  29. Jefferson City, Missouri
  30. Kalispell, Montana
  31. Las Vegas, Nevada
  32. Albuquerque, New Mexico
  33. Brooklyn, New York
  34. Brooklyn, New York
  35. Staten Island, New York
  36. Charlotte, North Carolina
  37. Wilmington, North Carolina
  38. Bismarck, North Dakota
  39. Fargo, North Dakota
  40. Cincinnati, Ohio
  41. Kettering, Ohio
  42. Mason, Ohio
  43. Norman, Oklahoma
  44. Oklahoma City, Oklahoma
  45. Bridgeville, Pennsylvania
  46. Philadelphia, Pennsylvania
  47. Pottstown, Pennsylvania
  48. Reading, Pennsylvania
  49. Greenville, South Carolina
  50. Mt. Pleasant, South Carolina
  51. Memphis, Tennessee
  52. San Antonio, Texas
  53. Bellevue, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl
Official Title  ICMJE An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Depression
Intervention  ICMJE Procedure: blood draw
Test Article was not provided to subjects for this study.
Study Arms  ICMJE 1
Intervention: Procedure: blood draw
Publications * Preskorn SH, Kane CP, Lobello K, Nichols AI, Fayyad R, Buckley G, Focht K, Guico-Pabia CJ. Cytochrome P450 2D6 phenoconversion is common in patients being treated for depression: implications for personalized medicine. J Clin Psychiatry. 2013 Jun;74(6):614-21. doi: 10.4088/JCP.12m07807. Epub 2013 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2010)
971
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2008)
865
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00788944
Other Study ID Numbers  ICMJE 0600B1-4433
B2411001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP