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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01432457
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : January 20, 2014
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
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 50 mg/day
Drug: desvenlafaxine succinate sustained-release 100 mg/day
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
Subjects were recruited in the United States from October 2011 to May 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to 2 weeks.

Reporting Groups
  Description
Placebo Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
DVS SR 50 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
DVS SR 100 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.

Participant Flow:   Overall Study
    Placebo   DVS SR 50 mg   DVS SR 100 mg
STARTED   306   306   312 
COMPLETED   269   258   253 
NOT COMPLETED   37   48   59 
Adverse Event                7                10                16 
Lack of Efficacy                2                1                1 
Lost to Follow-up                11                15                20 
Protocol Violation                3                2                6 
Withdrawal by Subject                6                11                9 
Reasons not defined                2                3                4 
Did not take study drug                6                6                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.
The numbers are correct. Participants flow starts with all randomized subjects while baseline is summarized for safety population defined as randomized AND took at least one dose. Started- (Other Did not take study drug) is the number for baseline summary.

Reporting Groups
  Description
Placebo Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
DVS SR 50 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
DVS SR 100 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Total Total of all reporting groups

Baseline Measures
   Placebo   DVS SR 50 mg   DVS SR 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 300   300   309   909 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.72  (12.42)   41.78  (13.56)   41.30  (12.80)   41.60  (12.92) 
Gender 
[Units: Participants]
       
Female   173   172   165   510 
Male   127   128   144   399 


  Outcome Measures

1.  Primary:   Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8   [ Time Frame: Baseline to Week 8 (final on-therapy) ]

2.  Primary:   Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8   [ Time Frame: Baseline to Week 8 (final on-therapy) ]

3.  Secondary:   Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)   [ Time Frame: Baseline to Week 8 (final on-therapy) ]

4.  Secondary:   Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)   [ Time Frame: Baseline to Week 8 (final on-therapy) ]

5.  Secondary:   Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score   [ Time Frame: Baseline to Week 8 (final on-therapy) ]

6.  Secondary:   Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate   [ Time Frame: Baseline to Week 8 (final on-therapy) ]

7.  Secondary:   Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate   [ Time Frame: Baseline to week 8 (final on-therapy) ]

8.  Secondary:   Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score   [ Time Frame: Baseline to Week 8 (final on-therapy) ]


  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: Pfizer
ClinicalTrials.gov Identifier: NCT01432457     History of Changes
Other Study ID Numbers: B2061028
3151A1-4420
First Submitted: September 9, 2011
First Posted: September 13, 2011
Results First Submitted: June 27, 2013
Results First Posted: January 20, 2014
Last Update Posted: January 20, 2014