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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

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ClinicalTrials.gov Identifier: NCT01371721
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE June 13, 2011
Results First Submitted Date  ICMJE April 19, 2016
Results First Posted Date  ICMJE February 8, 2017
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Percentage of Participants Experiencing a Treatment Emergent Adverse Event [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
Change from baseline to final on-therapy visit in the Children's Depression Rating Scale, Revised (CDRS-R) total score [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • 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 ]
    Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
  • 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 ]
    A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
  • 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 ]
    A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
  • 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 ]
    Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Clinical Global Impression - Improvement (CGI-I) score at the final on-therapy visit [ Time Frame: 6 months ]
  • Clinical Global Impression - Severity (CGI-S) score change from baseline at the final on-therapy visit [ Time Frame: 6 months ]
  • Clinical Global Impression - Improvement (CGI-I) response (score of 1 or 2) [ Time Frame: 6 months ]
  • Remission on the Children's Depression Rating Scale, Revised (CDRS-R) (score <=28) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Brief Summary This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Study Arms  ICMJE Experimental: Desvenlafaxine Succinate Sustained-Release
Intervention: Drug: DVS SR
Publications * Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2016)
269
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
333
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR
  • Willingness and ability to comply with scheduled visits, treatment plan and procedures

Exclusion Criteria:

  • Subject requires precaution against suicide
  • Subject not in a generally healthy condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01371721
Other Study ID Numbers  ICMJE B2061031
3151A6-3357 ( Other Identifier: Alias Study Number )
2008-002064-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP