Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00669110
First received: April 25, 2008
Last updated: April 21, 2011
Last verified: April 2011
Results First Received: April 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Depressive Disorder, Major Depressive Disorder
Intervention: Drug: Desvenlafaxine Succinate Sustained-Release Tablets (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
Eligible participants transitioned from preceding Core study NCT00619619 (3151A6-2000 [B2061012]) on Day 56 to this Extension study NCT00669110 (3151A6-2001 [B2061013]) to continue treatment on a flexible dose schedule. A total of 8 participants (Children n=2 and Adolescent n=6) discontinued during Taper/post-study or Follow-up phase of Core study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale - Improvement (CGI-I) = Inpatient Day 1 through 4 in the Core study and Baseline for the Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.

Reporting Groups
  Description
DVS SR - Children Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
DVS SR - Adolescents Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

Participant Flow:   Overall Study
    DVS SR - Children     DVS SR - Adolescents  
STARTED     20     20  
COMPLETED     12     7  
NOT COMPLETED     8     13  
Adverse Event                 4                 3  
Caregiver request                 3                 2  
Physician Decision                 0                 1  
Lost to Follow-up                 1                 0  
Protocol Violation                 0                 5  
Withdrawal by Subject                 0                 2  



  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 - Children Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
DVS SR - Adolescents Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Total Total of all reporting groups

Baseline Measures
    DVS SR - Children     DVS SR - Adolescents     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Mean ± Standard Deviation
  9.65  ± 1.31     13.55  ± 1.64     11.60  ± 2.46  
Gender  
[units: participants]
     
Female     11     9     20  
Male     9     11     20  
Number of participants for Tanner Assessment: Females [1]
[units: participants]
     
Breasts Stage 1     4     0     4  
Breasts Stage 2     4     1     5  
Breasts Stage 3     1     0     1  
Breasts Stage 4     0     1     1  
Breasts Stage 5     0     7     7  
Pubic hair Stage 1     6     0     6  
Pubic hair Stage 2     3     2     5  
Pubic hair Stage 3     0     0     0  
Pubic hair Stage 4     0     2     2  
Pubic hair Stage 5     0     5     5  
Number of participants for Tanner Assessment: Males [2]
[units: participants]
     
Penis Stage 1     5     0     5  
Penis Stage 2     3     2     5  
Penis Stage 3     1     2     3  
Penis Stage 4     0     3     3  
Penis Stage 5     0     3     3  
Pubic hair Stage 1     6     0     6  
Pubic hair Stage 2     2     1     3  
Pubic hair Stage 3     1     3     4  
Pubic hair Stage 4     0     4     4  
Pubic hair Stage 5     0     2     2  
Testes Stage 1     5     0     5  
Testes Stage 2     2     1     3  
Testes Stage 3     2     3     5  
Testes Stage 4     0     3     3  
Testes Stage 5     0     3     3  
[1] Female pubertal development of secondary sexual characteristics documented by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). N=9 Children, 9 Adolescent participants at observation. Participants may be represented in more than 1 test category.
[2] Male pubertal development of secondary sexual characteristics documented by size of genitalia and pubic hair development (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity, size). N=9 Children, 10 Adolescent participants at observation. Participants may be represented in > than 1 test category.



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline (Extension study) up to Extension study Week 29 Follow up visit ]

2.  Primary:   Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories   [ Time Frame: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study) ]

3.  Other Pre-specified:   Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit   [ Time Frame: Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination) ]

4.  Other Pre-specified:   Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)   [ Time Frame: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

5.  Other Pre-specified:   Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score   [ Time Frame: Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

6.  Other Pre-specified:   Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score   [ Time Frame: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

7.  Other Pre-specified:   Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score   [ Time Frame: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

8.  Other Pre-specified:   Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score   [ Time Frame: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

9.  Other Pre-specified:   Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females   [ Time Frame: Baseline (Extension study), Week 26 (Extension study) ]

10.  Other Pre-specified:   Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males   [ Time Frame: Baseline (Extension study), Week 26 (Extension study) ]

11.  Other Pre-specified:   Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)   [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

12.  Other Pre-specified:   Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight   [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

13.  Other Pre-specified:   Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate   [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

14.  Other Pre-specified:   Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)   [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

15.  Other Pre-specified:   Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)   [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

16.  Other Pre-specified:   Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)   [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00669110     History of Changes
Other Study ID Numbers: 3151A6-2001, B2061013
Study First Received: April 25, 2008
Results First Received: April 21, 2011
Last Updated: April 21, 2011
Health Authority: United States: Food and Drug Administration