Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

NCT00300378

Last updated date
Study Location
Rijeka, , 51000, Croatia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depressive Disorder, Major
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

- A primary diagnosis of MDD

- Depressive symptoms for at least 30 days before the screening visit.

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


- Treatment with DVS SR at any time in the past.


- Known hypersensitivity to venlafaxine


- Significant risk of suicide based on clinical judgment

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Depressive Disorder, MajorStudy Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder
NCT00300378
  1. Rijeka,
  2. Split,
  3. Zagreb,
  4. Tallinn,
  5. Tartu,
  6. Tartu,
  7. Espoo,
  8. Helsinki,
  9. Helsinki,
  10. Helsinki,
  11. Joensuu,
  12. Kuopio,
  13. Oulu,
  14. Rauma,
  15. Salo,
  16. Turku,
  17. Caen,
  18. Dole,
  19. Douai,
  20. Mulhouse,
  21. Orvault,
  22. Rennes,
  23. Tours,
  24. Jelgava,
  25. Liepaja,
  26. Riga,
  27. Strenci,
  28. Kaunas,
  29. Klaipeda,
  30. Vilnius,
  31. Lubiaz,
  32. Tuszyn,
  33. Zuromin,
  34. Bucuresti,
  35. Bucuresti,
  36. Craiova,
  37. Bojnice,
  38. Bratislava,
  39. Rimavska Sobota,
  40. Bloemfontein,
  41. Cape Town,
  42. Durban,
  43. Pretoria,
ALL GENDERS
18 Years+
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: desvenlafaxine 50 mg
  • Drug: desvenlafaxine 100 mg
Study Arms  ICMJE Not Provided
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
Estimated Enrollment  ICMJE
 (submitted: March 7, 2006)
480
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A primary diagnosis of MDD
  • Depressive symptoms for at least 30 days before the screening visit.

Exclusion Criteria:

  • Treatment with DVS SR at any time in the past.
  • Known hypersensitivity to venlafaxine
  • Significant risk of suicide based on clinical judgment
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 Croatia,   Estonia,   Finland,   France,   Latvia,   Lithuania,   Poland,   Romania,   Slovakia,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300378
Other Study ID Numbers  ICMJE 3151A1-333
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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 France, [email protected]
Principal Investigator:Trial ManagerFor Estonia, Latvia, Lithuania, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Finland, [email protected]
Principal Investigator:Trial ManagerFor Croatia, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Slovakia, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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