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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00798707
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : June 6, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
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 (DVS SR)
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 907 potential participants were screened for this study. 813 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 25 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 25 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 25 mg   DVS SR 50 mg
STARTED   235   237   237 
Treated   231   232   236 
COMPLETED   209   204   215 
NOT COMPLETED   26   33   22 
Adverse Event                6                8                8 
Failed to return                2                2                0 
Investigator                0                1                2 
Lack of Efficacy                2                2                1 
Lost to Follow-up                5                6                6 
Other                0                1                0 
Protocol Violation                4                0                2 
Withdrawal by Subject                3                8                2 
Randomized not treated                4                5                1 



  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 25 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 25 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 25 mg   DVS SR 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 231   232   236   699 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.26  (12.32)   40.19  (11.88)   38.59  (12.08)   39.67  (12.10) 
Gender 
[Units: Participants]
       
Female   128   127   131   386 
Male   103   105   105   313 
Hamilton Psychiatric Scale for Depression-17 item (HAM-D17) total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 23.06  (2.59)   23.08  (2.93)   22.81  (2.61)   22.98  (2.71) 
[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.
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.39  (0.59)   4.35  (0.57)   4.33  (0.56)   4.36  (0.58) 
[1] 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.
Montgomery-Asberg Depression Rating Scale (MADRS) total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 28.19  (5.74)   28.08  (5.46)   28.21  (5.38)   28.16  (5.52) 
[1] 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).
HAM-D6 total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 12.58  (1.79)   12.61  (1.77)   12.43  (1.75)   12.54  (1.77) 
[1] 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.
Sheehan Disability Scale (SDS) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16.31  (7.78)   17.02  (7.34)   16.39  (7.27)   16.57  (7.46) 
[1] 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.
World Health Organization 5-Item Well-Being Index (WHO-5) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 7.21  (4.47)   6.89  (3.99)   7.18  (4.34)   7.09  (4.27) 
[1] 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).
Participants with Sexual dysfunction [1] 
[Units: Percentage of Participants]
 66.4   66.1   62.3   194.8 
[1] 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.
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   31   45   37   113 
[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 the 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) Total Score   [ 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, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00798707     History of Changes
Other Study ID Numbers: 3151A1-3359
B2061003
3151A1-3359-WW
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: March 7, 2011
Results First Posted: June 6, 2011
Last Update Posted: June 10, 2011