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Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831415
First Posted: January 29, 2009
Last Update Posted: January 30, 2012
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.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: December 22, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: desvenlafaxine succinate sustained release tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a 10-month, open-label, multicenter study of Japanese participants with Major Depressive Disorder (MDD) conducted from March 2009 to March 2011 at 61 sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 304 participants who completed the short-term Core Study (NCT00798707 [3151A1-3359 / B2061003]) consented to enroll in this long-term, open-label, flexible dosing Extension study (NCT00831415 [3151A1-3350 / B2061002]). Baseline in this Extension study = Day 56 of the Core study.

Reporting Groups
  Description
DVS SR Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.

Participant Flow:   Overall Study
    DVS SR
STARTED   304 
Completers for "Exposure"   227 [1] 
Study "Completers"   227 [2] 
COMPLETED   229 [3] 
NOT COMPLETED   75 
Adverse Event                14 
Failed to return                3 
Physician Decision                6 
Lost to Follow-up                9 
Protocol Violation                3 
Withdrawal by Subject                35 
Unsatisfactory response - Efficacy                4 
Death                1 
[1] Participants with ≥ 301 days of exposure to study drug and completed study day 308 evaluations.
[2] Defined as participants whose conclusion of study participation status was “study completed.”
[3] In addition to Completers for Study includes 2 participants who discontinued after on-therapy period



  Baseline Characteristics
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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 DVS SR flexible dose 25 mg/day up to 100 mg/day.

Baseline Measures
   DVS SR 
Overall Participants Analyzed 
[Units: Participants]
 304 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.45  (10.81) 
Gender 
[Units: Participants]
 
Female   149 
Male   155 
Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 12.86  (6.30) 
[1] HAM-D17 is 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. Higher scores indicate greater severity.
Categorical scores on Clinical Global Impression-Improvement [CGI-I] [1] 
[Units: Participants]
 
1=Very much improved   75 
2=Much improved   81 
3=Minimally improved   94 
4=No change   51 
5=Minimally worse   3 
[1] CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Baseline for CGI-I in this Extension study (NCT00831415 [3151A1-3350 / B2061002]) was measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).
Clinical Global Impression-Severity of Illness [CGI-S] score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 3.25  (1.11) 
[1] CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.


  Outcome Measures
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1.  Primary:   Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score   [ Time Frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation ]

2.  Primary:   Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment ]

3.  Secondary:   Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)   [ Time Frame: Day 308 or FOT Evaluation ]

4.  Secondary:   Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score   [ Time Frame: Baseline (Extension Study) up to Day 308 or FOT Evaluation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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.govCallCenter@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00831415     History of Changes
Other Study ID Numbers: 3151A1-3350
B2061002
First Submitted: January 27, 2009
First Posted: January 29, 2009
Results First Submitted: December 22, 2011
Results First Posted: January 30, 2012
Last Update Posted: January 30, 2012