Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

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NCT00406640

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Study Location
Peoria, Arizona, 85381, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Depressive Disorder, Depressive Disorder, Major
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal women between the ages of 40 and 70 years, inclusive.

- A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI).

- Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.

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


- Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator
(SERM)-containing drug products 8 weeks before baseline.


- Current (within 12 months) psychoactive substance abuse or dependence (including
alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive
disorder, or a lifetime diagnosis of bipolar or psychotic disorder.


- A history or active presence of clinically important medical disease.


Additional criteria apply.

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Depression, Depressive Disorder, Depressive Disorder, MajorStudy Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
NCT00406640
  1. Peoria, Arizona
  2. Pasadena, California
  3. San Diego, California
  4. San Diego, California
  5. Denver, Colorado
  6. Cromwell, Connecticut
  7. Farmington, Connecticut
  8. Waterbury, Connecticut
  9. Brooksville, Florida
  10. Coral Springs, Florida
  11. Fort Meyers, Florida
  12. Gainesville, Florida
  13. Maitland, Florida
  14. Atlanta, Georgia
  15. Roswell, Georgia
  16. Northfield, Illinois
  17. Oak Brook, Illinois
  18. Overland Park, Kansas
  19. Witchita, Kansas
  20. New Orleans, Louisiana
  21. Shreveport, Louisiana
  22. Baltimore, Maryland
  23. Boston, Massachusetts
  24. Fall River, Massachusetts
  25. St. Paul, Minnesota
  26. Las Vegas, Nevada
  27. Piscataway, New Jersey
  28. Elmsford, New York
  29. Holliswood, New York
  30. New York, New York
  31. New York, New York
  32. Syracuse, New York
  33. Raleigh, North Carolina
  34. Oklahoma City, Oklahoma
  35. Philadelphia, Pennsylvania
  36. Pittsburgh, Pennsylvania
  37. Pittsburgh, Pennsylvania
  38. East Providence, Rhode Island
  39. Lincoln, Rhode Island
  40. Charleston, South Carolina
  41. Columbia, South Carolina
  42. Mt. Pleasant, South Carolina
  43. Memphis, Tennessee
  44. Bellaire, Texas
  45. Dallas, Texas
  46. Denton, Texas
  47. Houston, Texas
  48. Burlington, Vermont
  49. Charlottesville, Virginia
  50. Richmond, Virginia
  51. Morgantown, West Virginia
  52. Middleton, Wisconsin
  53. Buenos Aires,
  54. Buenos Aires,
  55. Buenos Aires,
  56. Buenos Aires,
  57. Buenos Aires,
  58. Buenos Aires,
  59. Buenos Aires,
  60. La Plata,
  61. Mendoza,
  62. Santiago,
  63. Barranquilla,
  64. Bogota,
  65. Bucamaranga,
  66. Mexico City,
  67. Monterrey,
  68. Tobasco,
  69. Chiclayo,
  70. Lima,
Female
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
Official Title  ICMJE A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder
Brief Summary Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depressive Disorder
  • Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Desvenlafaxine succinate sustained-release (DVS SR)
    flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.
  • Drug: Escitalopram
    Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Desvenlafaxine succinate sustained-release (DVS SR)
  • Active Comparator: B
    Intervention: Drug: Escitalopram
Publications * Soares CN, Thase ME, Clayton A, Guico-Pabia CJ, Focht K, Jiang Q, Kornstein SG, Ninan PT, Kane CP. Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. CNS Drugs. 2011 Mar;25(3):227-38. doi: 10.2165/11586460-000000000-00000.

*   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 26, 2010)		595
Original Enrollment  ICMJE
 (submitted: November 29, 2006)		500
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women between the ages of 40 and 70 years, inclusive.
  • A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI).
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.

Exclusion Criteria:

  • Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
  • Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
  • A history or active presence of clinically important medical disease.

Additional criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 40 Years to 70 Years   (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 Argentina,   Chile,   Colombia,   Mexico,   Peru,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00406640
Other Study ID Numbers  ICMJE 3151A1-402
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Argentina: [email protected]
Principal Investigator:Trial ManagerFor Chile: [email protected]
Principal Investigator:Trial ManagerFor Mexico: [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2010

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