Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00863798
First received: March 17, 2009
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
Results First Received: March 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
  Hide 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  
Unspecified                 2                 3                 1  
Protocol Violation                 0                 1                 1  
Withdrawal by Subject                 8                 7                 4  
Randomized not treated                 4                 2                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

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  
Number of Participants  
[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 [2]
[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 [3]
[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 [4]
[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 [5]
[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) [6]
[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 [7]
[units: Percentage of Participants]
 		  58.8     61.3     65.8     185.9  
Participants with Columbia Suicide-Severity Rating Scale (C-SSRS) total score [8]
[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] HAM-D17 : a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
[2] CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
[3] MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
[4] HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items associated with major depression and is a subset of the HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.
[5] SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities.Participant rates extent to which each of these domains are impaired by his/her symptoms using 10 point visual analog scale:(0=not at all impaired,10=extremely impaired) for total maximum score of 30.
[6] WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 ( 0= worst possible quality of life; 25=best possible quality of life).
[7] Arizona Sexual Experiences Scale (ASEX) includes 5 questions that evaluate sexual function exclusively during week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
[8] 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
  Show All 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) ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

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 ) ]
  Show Outcome Measure 3

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

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 ) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 6

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) ]
  Show Outcome Measure 7

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) ]
  Show Outcome Measure 8

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) ]
  Show Outcome Measure 9

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

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

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) ]
  Show Outcome Measure 12

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

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) ]
  Show Outcome Measure 14

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide 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.


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


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

Publications automatically indexed to this study:


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
Study First Received: March 17, 2009
Results First Received: March 8, 2011
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration