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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00831415
First received: January 27, 2009
Last updated: December 22, 2011
Last verified: December 2011
Results First Received: December 22, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: desvenlafaxine succinate sustained release tablets

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

Baseline Measures
    DVS SR  
Number of Participants  
[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  
Categorical scores on Clinical Global Impression-Improvement [CGI-I] [2]
[units: participants]
 
1=Very much improved     75  
2=Much improved     81  
3=Minimally improved     94  
4=No change     51  
5=Minimally worse     3  
Clinical Global Impression-Severity of Illness [CGI-S] score [3]
[units: scores on a scale]
Mean ± Standard Deviation
  3.25  ± 1.11  
[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.
[2] 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]).
[3] 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
  Show All Outcome Measures

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
  Hide 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
  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.


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00831415     History of Changes
Other Study ID Numbers: 3151A1-3350, B2061002
Study First Received: January 27, 2009
Results First Received: December 22, 2011
Last Updated: December 22, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
United States: Institutional Review Board