Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

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NCT00369343

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Study Location
Birmingham, Alabama, 35226, 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, Major Depressive Disorder
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

- Peri- and 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 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, Major Depressive DisorderStudy Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
NCT00369343
  1. Birmingham, Alabama
  2. Little Rock, Arkansas
  3. Springdale, Arkansas
  4. Palo Alto, California
  5. San Diego, California
  6. New London, Connecticut
  7. Bradenton, Florida
  8. Miami, Florida
  9. Tampa, Florida
  10. Winter Park, Florida
  11. Atlanta, Georgia
  12. Sandy Springs, Georgia
  13. Savannah, Georgia
  14. Smyrna, Georgia
  15. Idaho Falls, Idaho
  16. Chicago, Illinois
  17. Indianapolis, Indiana
  18. Terre Haute, Indiana
  19. Shreveport, Louisiana
  20. Rockville, Maryland
  21. Omaha, Nebraska
  22. Cherry Hill, New Jersey
  23. Brooklyn, New York
  24. Minot, North Dakota
  25. Beachwood, Ohio
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  28. Oklahoma City, Oklahoma
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Official Title  ICMJE A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder
Brief Summary Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depressive Disorder
  • Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
    DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
  • Drug: Placebo
    Placebo, daily (QD), tablet form, treatment period up to 8 weeks
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Publications *

*   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: April 9, 2012)		381
Original Enrollment  ICMJE
 (submitted: August 25, 2006)		345
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Peri- and 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 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00369343
Other Study ID Numbers  ICMJE 3151A1-403
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2012

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