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A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01371721
First received: June 9, 2011
Last updated: December 16, 2016
Last verified: December 2016
Results First Received: April 19, 2016  
Study Type: Interventional
Study Design: Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: DVS SR

  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
Participants who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 NCT01372150) and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo / DVS SR Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine / DVS SR Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Desvenlafaxine Succinate Sustained Release / DVS SR DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

Participant Flow:   Overall Study
    Placebo / DVS SR   Fluoxetine / DVS SR   Desvenlafaxine Succinate Sustained Release / DVS SR
STARTED   88   89   92 
Treated   87   89   92 
COMPLETED   59   65   62 
NOT COMPLETED   29   24   30 
Adverse Event                5                4                5 
Protocol Violation                6                4                5 
Lost to Follow-up                8                2                6 
Withdrawal by Subject                5                7                11 
Not specified                2                3                0 
Lack of Efficacy                2                4                3 
Randomized but not treated                1                0                0 



  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.
Safety population - included all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Placebo / DVS SR Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine / DVS SR Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Desvenlafaxine Succinate Sustained Release / DVS SR DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Total Total of all reporting groups

Baseline Measures
   Placebo / DVS SR   Fluoxetine / DVS SR   Desvenlafaxine Succinate Sustained Release / DVS SR   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   89   92   268 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.5  (2.90)   12.4  (3.01)   12.8  (3.14)   12.6  (3.01) 
Gender 
[Units: Participants]
Count of Participants
       
Female      47  54.0%      39  43.8%      49  53.3%      135  50.4% 
Male      40  46.0%      50  56.2%      43  46.7%      133  49.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Experiencing a Treatment Emergent Adverse Event   [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]

2.  Secondary:   Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases   [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]

3.  Secondary:   Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases   [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]

4.  Secondary:   Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26   [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]

5.  Secondary:   Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases   [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]

6.  Secondary:   Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases   [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]


  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.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371721     History of Changes
Other Study ID Numbers: B2061031
3151A6-3357 ( Other Identifier: Alias Study Number )
2008-002064-34 ( EudraCT Number )
Study First Received: June 9, 2011
Results First Received: April 19, 2016
Last Updated: December 16, 2016