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A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: April 29, 2016
Last verified: April 2016
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: desvenlafaxine succinate sustained release
Drug: fluoxetine
Drug: placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
Fluoxetine Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
Desvenlafaxine Succinate Sustained Release (DVS SR) DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.

Participant Flow:   Overall Study
    Placebo   Fluoxetine   Desvenlafaxine Succinate Sustained Release (DVS SR)
STARTED   112   113   115 
Treated   112   112   115 
COMPLETED   99   99   99 
NOT COMPLETED   13   14   16 
Lack of Efficacy                3                0                1 
Lost to Follow-up                4                5                6 
Protocol Violation                1                0                3 
Withdrawal by Subject                2                7                2 
Other                1                0                2 
Adverse Event                2                1                2 
Randomized but not treated                0                1                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 Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
Fluoxetine Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
DVS SR DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
Total Total of all reporting groups

Baseline Measures
   Placebo   Fluoxetine   DVS SR   Total 
Overall Participants Analyzed 
[Units: Participants]
 112   112   115   339 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.6  (2.89)   12.6  (2.89)   12.9  (3.12)   12.7  (2.96) 
Gender 
[Units: Participants]
       
Female   64   57   63   184 
Male   48   55   52   155 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score   [ Time Frame: Baseline and Week 8 ]

3.  Secondary:   Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8   [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8 ]

4.  Secondary:   Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'   [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: NCT01372150     History of Changes
Other Study ID Numbers: B2061014
3151A6-3356 ( Other Identifier: Alias Study Number )
2008-002063-13 ( EudraCT Number )
Study First Received: June 9, 2011
Results First Received: October 19, 2015
Last Updated: April 29, 2016
Health Authority: United States: Food and Drug Administration