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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00369343
First received: August 25, 2006
Last updated: April 9, 2012
Last verified: April 2012
Results First Received: November 26, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Interventions: Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in the United States from September 2006 to September 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened over 4 weeks.

Reporting Groups
  Description
Desvenlafaxine Succinate Sustained-Release (DVS SR) Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Placebo Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.

Participant Flow for 2 periods

Period 1:   Double-blind Phase
    Desvenlafaxine Succinate Sustained-Release (DVS SR)     Placebo  
STARTED     256     125  
COMPLETED     212     109  
NOT COMPLETED     44     16  
Adverse Event                 19                 4  
Failed to return                 2                 0  
Lost to Follow-up                 9                 2  
Protocol Violation                 2                 0  
Withdrawal by Subject                 8                 6  
Lack of Efficacy                 0                 4  
Protocol deviation                 4                 0  

Period 2:   Open-label Phase
    Desvenlafaxine Succinate Sustained-Release (DVS SR)     Placebo  
STARTED     212     109  
COMPLETED     155     79  
NOT COMPLETED     57     30  
Adverse Event                 19                 7  
Failed to return                 4                 0  
Physician Decision                 2                 0  
Lost to Follow-up                 5                 3  
inadvertently reported study completers                 3                 2  
Protocol Violation                 1                 3  
Withdrawal by Subject                 15                 6  
Lack of Efficacy                 4                 3  
Lack of continuance tolerability                 3                 4  
did not take study drug                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Desvenlafaxine Succinate Sustained-Release (DVS SR) Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Placebo Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Total Total of all reporting groups

Baseline Measures
    Desvenlafaxine Succinate Sustained-Release (DVS SR)     Placebo     Total  
Number of Participants  
[units: participants]
  256     125     381  
Age  
[units: years]
Mean ± Standard Deviation
  52.01  ± 6.50     52.56  ± 7.17     52.19  ± 6.72  
Gender  
[units: participants]
     
Female     256     125     381  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.   [ Time Frame: Baseline to 8 weeks ]

2.  Secondary:   Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score   [ Time Frame: 8 weeks ]

3.  Secondary:   Percentage of Patients Achieving Remission   [ Time Frame: 8 weeks ]

4.  Secondary:   Percentage of Patients Achieving Response to Treatment   [ Time Frame: 8 weeks ]

5.  Secondary:   Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8   [ Time Frame: Baseline to 8 weeks ]

6.  Secondary:   Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8   [ Time Frame: Baseline to 8 weeks ]

7.  Secondary:   Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months   [ Time Frame: open label baseline and 6 months ]

8.  Secondary:   Clinical Global Impression Improvement (CGI-I) Score   [ Time Frame: 6 months ]

9.  Secondary:   Percentage of Patients Achieving Remission   [ Time Frame: 6 months ]

10.  Secondary:   Percentage of Patients Achieving a Response to Treatment   [ Time Frame: 6 months ]

11.  Secondary:   Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months   [ Time Frame: open label baseline to 6 months ]

12.  Secondary:   Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months   [ Time Frame: open label baseline to 6 months ]

13.  Secondary:   Discontinuation-Emergent Signs and Symptoms (DESS) Total Score   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00369343     History of Changes
Other Study ID Numbers: 3151A1-403
Study First Received: August 25, 2006
Results First Received: November 26, 2008
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration