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Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00824291
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : November 25, 2010
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: desvenlafaxine succinate sustained release
Genetic: Genotyping

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 752 potential participants were screened for this study. 437 participants were randomized to treatment groups while 315 participants were not randomized (288: did not meet the study criteria; 27 were not randomized for other reasons). Of the 437 randomized participants, 10 participants did not receive the study treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DVS SR 50 mg Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Placebo Participants were administered an oral dose of placebo once daily with or without food.

Participant Flow:   Overall Study
    DVS SR 50 mg   Placebo
STARTED   285   142 
COMPLETED   231   107 
NOT COMPLETED   54   35 
Adverse Event                15                6 
Discontinuation of Study by Sponsor                1                2 
Lost to Follow-up                11                9 
Non-compliance                1                1 
Protocol Violation                4                1 
Withdrawal by Subject                14                8 
Lack of Efficacy                7                8 
Participant on prohibited medication                1                0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
DVS SR 50 mg Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Placebo Participants were administered an oral dose of placebo once daily with or without food.
Total Total of all reporting groups

Baseline Measures
   DVS SR 50 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 285   142   427 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.16  (11.72)   41.57  (12.64)   42.63  (12.04) 
Gender 
[Units: Participants]
     
Female   188   93   281 
Male   97   49   146 


  Outcome Measures

1.  Primary:   Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12   [ Time Frame: At Baseline and Week 12. ]

2.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12   [ Time Frame: At Baseline and Week 12. ]

3.  Secondary:   Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12   [ Time Frame: At Baseline and Week 12. ]

4.  Secondary:   Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12   [ Time Frame: At Baseline and Week 12. ]

5.  Secondary:   Change From Baseline on Work and Activities Item of HAM-D17 at Week 12   [ Time Frame: At Baseline and Week 12. ]

6.  Secondary:   Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12   [ Time Frame: At Baseline and Week 12. ]

7.  Secondary:   Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12   [ Time Frame: At Baseline and Week 12. ]

8.  Secondary:   Change From Baseline on Stress and Social Support Scales at Week 12   [ Time Frame: At Baseline and Week 12. ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00824291     History of Changes
Other Study ID Numbers: 3151A1-4415
B2061006
First Submitted: January 14, 2009
First Posted: January 16, 2009
Results First Submitted: October 26, 2010
Results First Posted: November 25, 2010
Last Update Posted: March 10, 2011