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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01371708
First received: June 9, 2011
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
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).

Condition Intervention Phase
Major Depressive Disorder
Drug: DVS SR
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) [ Time Frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 283
Study Start Date: February 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desvenlafaxine Succinate Sustained-Release Drug: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371708

  Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371708     History of Changes
Other Study ID Numbers: B2061030  3151A6-3344  2008-001876-67 
Study First Received: June 9, 2011
Results First Received: October 14, 2016
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Major Depressive Disorder
MDD
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on December 09, 2016