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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
This study has been completed.
Study NCT00406640   Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on November 29, 2006.   Last Updated on May 26, 2010   History of Changes
Results First Received: February 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Interventions: Drug: Desvenlafaxine succinate sustained-release (DVS SR)
Drug: Escitalopram

  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
Subjects were recruited in Argentina, Chile, Colombia, Mexico and the United States from December 2006 to January 2008.

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

Reporting Groups
  Description
Desvenlafaxine Succinate Sustained-release (DVS SR) Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Escitalopram Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.

Participant Flow for 3 periods

 Period 1:   Acute Phase
    Desvenlafaxine Succinate Sustained-release (DVS SR)     Escitalopram  
STARTED     296     299  
COMPLETED     245     256  
NOT COMPLETED     51     43  
Adverse Event                 18                 13  
Failed to Return                 5                 1  
Physician Decision                 0                 1  
Lost to Follow-up                 7                 4  
Protocol deviation                 4                 10  
Protocol Violation                 3                 2  
Withdrawal by Subject                 11                 9  
Lack of Efficacy                 3                 3  

Period 2:   DB Continuation Phase for Responders
    Desvenlafaxine Succinate Sustained-release (DVS SR)     Escitalopram  
STARTED     172     188  
COMPLETED     139     151  
NOT COMPLETED     33     37  
Adverse Event                 11                 11  
Death                 1                 0  
Failed to Return                 0                 2  
Physician Decision                 2                 3  
Lost to Follow-up                 1                 7  
non-compliance                 7                 5  
Protocol Violation                 2                 2  
Withdrawal by Subject                 8                 6  
Lack of Efficacy                 1                 1  

Period 3:   OL Extension Phase for Non-Responders
    Desvenlafaxine Succinate Sustained-release (DVS SR)     Escitalopram  
STARTED     69     60  
COMPLETED     47     36  
NOT COMPLETED     22     24  
Adverse Event                 6                 6  
Failed to Return                 1                 0  
Physician Decision                 1                 0  
Lost to Follow-up                 2                 3  
non-compliance                 3                 2  
Withdrawal by Subject                 3                 6  
Lack of Efficacy                 6                 7  



  Baseline Characteristics
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Reporting Groups
  Description
Desvenlafaxine Succinate Sustained-release (DVS SR) Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Escitalopram Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.

Baseline Measures
    Desvenlafaxine Succinate Sustained-release (DVS SR)     Escitalopram     Total  
Number of Participants  
[units: participants]
 		  296     299     595  
Age  
[units: years]
Mean ± Standard Deviation 		  55.78  ± 6.13     56.15  ± 6.25     55.97  ± 6.19  
Gender  
[units: participants]
 		     
Female     296     299     595  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     211     219     430  
Mexico     10     9     19  
Argentina     43     42     85  
Chile     11     9     20  
Colombia     21     20     41  



  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 and 8 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)   [ Time Frame: 8 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)   [ Time Frame: 8 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks   [ Time Frame: 8 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week   [ Time Frame: Baseline and 8 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 6

7.  Secondary:   Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8   [ Time Frame: Baseline and week 8 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)   [ Time Frame: 6 months ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)   [ Time Frame: 6 months ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase   [ Time Frame: 6 months ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase   [ Time Frame: 6 months ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase   [ Time Frame: 6 months ]
  Show Outcome Measure 12

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


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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:
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 1;25(3):227-38.


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00406640     History of Changes
Other Study ID Numbers: 3151A1-402
Study First Received: November 29, 2006
Results First Received: February 27, 2009
Last Updated: May 26, 2010
Health Authority: United States: Food and Drug Administration





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