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Trial record 1 of 1 for:    NCT01371708
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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

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ClinicalTrials.gov Identifier: NCT01371708
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : December 8, 2016
Last Update Posted : July 27, 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 October 14, 2016
Results First Posted Date  ICMJE December 8, 2016
Last Update Posted Date July 27, 2017
Actual Study Start Date  ICMJE February 2, 2012
Actual Primary Completion Date April 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
  • Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
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 Complete list of historical versions of study NCT01371708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
  • Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
  • Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ]
    Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
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 Scale (CGI S) score change from baseline at the final on therapy visit [ Time Frame: 6 months ]
  • CGI I response (score of 1 or 2) [ Time Frame: 6 months ]
  • Remission on the 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 Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Official Title  ICMJE A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 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 Intervention Model: Single Group Assignment
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 * Not Provided

*   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: July 5, 2016)
283
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
333
Actual Study Completion Date  ICMJE April 22, 2016
Actual Primary Completion Date April 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completed study B2061032 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:

  • Requires precaution against suicide
  • Not in generally healthy medical condition
  • Poor compliance with study drug or study procedures during participation in study B2061032
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 Chile,   United States
Removed Location Countries Mexico,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01371708
Other Study ID Numbers  ICMJE B2061030
3151A6-3344 ( Other Identifier: Alias Study Number )
2008-001876-67 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 June 2017

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