ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 1857 for:    "Depressive Disorder" [DISEASE] | "Depressive Disorder, Major"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00863798
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Sponsor:
Collaborator:
Pfizer
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: Major Depressive Disorder
Interventions: Drug: Desvenlafaxine Succinate Sustained-Release 10mg
Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 898 potential participants were screened for this study. 804 participants were enrolled and received single-blind placebo during the screening period prior to randomization.

Reporting Groups
  Description
Placebo Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
DVS SR 10 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg DVS SR 50 mg daily until Day 56 (Week 8) or ET.

Participant Flow:   Overall Study
    Placebo   DVS SR 10 mg   DVS SR 50 mg
STARTED   227   228   227 
Treated   223   226   224 
COMPLETED   195   198   202 
NOT COMPLETED   32   30   25 
Adverse Event                5                2                4 
Participant failed to return                2                1                0 
Investigator request                1                2                1 
Lack of Efficacy                4                3                6 
Lost to Follow-up                6                9                5 
Other                2                3                1 
Protocol Violation                0                1                1 
Withdrawal by Subject                8                7                4 
Randomized not treated                4                2                3 



  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
Placebo Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
DVS SR 10 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Total Total of all reporting groups

Baseline Measures
   Placebo   DVS SR 10 mg   DVS SR 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 223   226   224   673 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.75  (12.85)   41.01  (13.75)   42.47  (13.47)   41.74  (13.36) 
Gender 
[Units: Participants]
       
Female   139   135   135   409 
Male   84   91   89   264 
Hamilton Psychiatric Scale for Depression-17 item HAM-D17) total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 23.23  (2.63)   22.83  (2.26)   23.12  (2.62)   23.06  (2.51) 
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.14  (0.35)   4.14  (0.34)   4.16  (0.39)   4.14  (0.36) 
Montgomery-Asberg Depression Rating Scale (MADRS) total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 28.33  (4.71)   27.59  (4.49)   28.44  (4.83)   28.12  (4.69) 
HAM-D6 total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 12.72  (1.51)   12.77  (1.41)   12.63  (1.49)   12.71  (1.47) 
Sheehan Disability Scale (SDS) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16.88  (8.25)   16.42  (8.37)   17.06  (7.73)   16.78  (8.12) 
World Health Organization 5-Item Well-Being Index (WHO-5) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 7.39  (4.80)   7.47  (4.86)   7.06  (4.26)   7.31  (4.65) 
Participants with Sexual dysfunction [1] 
[Units: Percentage of Participants]
 58.8   61.3   65.8   185.9 
Participants with Columbia Suicide-Severity Rating Scale (C-SSRS) total score [1] 
[Units: Participants]
       
Completed Suicide   0   0   0   0 
Suicide Attempt   0   0   0   0 
Preparatory acts toward imminent suicidal behavior   0   0   0   0 
Suicidal ideation   37   31   29   97 
[1] C-SSRS was mapped into Columbia Classification Algorithm of Suicide Assessment (C-CASA)(1-4) to prospectively assess whether participants experienced: completed suicide(1),suicide attempt(2),preparatory acts toward imminent suicidal behavior(3),suicidal ideation,any suicidal behavior and ideation(4).Participants with “yes” response were reported.


  Outcome Measures

1.  Primary:   Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)   [ Time Frame: Baseline and Week 8 (or ET) ]

2.  Secondary:   Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

3.  Secondary:   Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)   [ Time Frame: Baseline and Week 8 (or ET ) ]

4.  Secondary:   Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)   [ Time Frame: Baseline and Week 8 (or ET) ]

5.  Secondary:   Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)   [ Time Frame: Baseline and Week 8 (or ET ) ]

6.  Secondary:   Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

7.  Secondary:   Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

8.  Secondary:   Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

9.  Secondary:   Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

10.  Other Pre-specified:   Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations   [ Time Frame: Week 2, 4 and 8 (or ET) ]

11.  Other Pre-specified:   Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)   [ Time Frame: Baseline and Week 8 (or ET) ]

12.  Other Pre-specified:   Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)   [ Time Frame: Baseline and Week 8 (or ET) ]

13.  Other Pre-specified:   Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

14.  Other Pre-specified:   Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)   [ Time Frame: Week 8 (or ET) ]

15.  Other Pre-specified:   Discontinuation-Emergent Signs and Symptoms (DESS)   [ Time Frame: Week 8 to 10 (or ET) ]


  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, Wyeth
ClinicalTrials.gov Identifier: NCT00863798     History of Changes
Other Study ID Numbers: 3151A1-3362
B2061005
3151A1-3362-US
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: March 8, 2011
Results First Posted: May 6, 2011
Last Update Posted: May 6, 2011