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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: June 9, 2011
• First Posted Date: June 13, 2011
• Results First Submitted Date: October 14, 2016
• Results First Posted Date: December 8, 2016
• Last Update Posted Date: July 27, 2017
• Actual Study Start Date: February 2, 2012
• Actual Primary Completion Date: April 22, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

Drug: DVS SR

Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

Study Arms

Experimental: Desvenlafaxine Succinate Sustained-Release

Intervention: Drug: DVS SR

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 5, 2016): 283
• Original Estimated Enrollment (submitted: June 10, 2011): 333
• Actual Study Completion Date: April 22, 2016
• Actual Primary Completion Date: April 22, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 7 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile, United States
• Removed Location Countries: Mexico, Puerto Rico

Administrative Information

• NCT Number: NCT01371708
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2017