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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2008-001876-67
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    22 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Nov 2016
    First version publication date
    03 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B2061030
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01371708
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias ID: 3151A6-3344
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This Phase 3, multi-center, open-label, flexible-dose extension study of desvenlafaxine succinate sustained-release (DVS SR) in the treatment of child (7 to 11 years of age) and adolescent (12 to 17 years of age) outpatients with Major Depressive Disorder (MDD) who completed the preceding double-blind study (B2061032) aimed to evaluate the long-term safety, tolerability and efficacy of DVS SR in the treatment of children and adolescents with MDD.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. The final protocol and any amendments were reviewed and approved by the Institutional Review Board(s) and/or Independent Ethics Committee(s) at each of the investigational centres participating in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 282
    Country: Number of subjects enrolled
    Chile: 1
    Worldwide total number of subjects
    283
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    87
    Adolescents (12-17 years)
    196
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants completing study B2061032 who, in the Investigator’s opinion, would benefit from long-term treatment with DVS SR, may have been eligible for this extension study. Of the 304 participants completing study B2061032, 283 transitioned to this study at the Week 8 visit of the preceding double-blind study. Of these, 281 received treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/DVS-SR
    Arm description
    Participants received placebo tablets in previous study B2061032 and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
    Arm type
    Experimental

    Investigational medicinal product name
    Desvenlafaxine succinate sustained-release
    Investigational medicinal product code
    Other name
    DVS SR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo in the previous study B2061032, and DVS SR in this extension study B2061030 in a flexible dosing regimen (20, 25, 35, or 50 mg/day as clinically indicated) of up to 26 weeks, followed by a taper phase of up to 2 weeks.

    Arm title
    DVS-SR, low dose/DVS-SR
    Arm description
    Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
    Arm type
    Experimental

    Investigational medicinal product name
    Desvenlafaxine succinate sustained-release
    Investigational medicinal product code
    Other name
    DVS SR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received DVS SR in weight based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS SR in this extension study B2061030 in a flexible dosing regimen (20, 25, 35, or 50 mg/day as clinically indicated) of up to 26 weeks, followed by a taper phase of up to 2 weeks.

    Arm title
    DVS-SR, high dose/DVS-SR
    Arm description
    Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
    Arm type
    Experimental

    Investigational medicinal product name
    Desvenlafaxine succinate sustained-release
    Investigational medicinal product code
    Other name
    DVS SR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received DVS SR in weight based dosing (20, 25, or 50 mg) in previous study B2061032, and DVS SR in this extension study B2061030 in a flexible dosing regimen (20, 25, 35, or 50 mg/day as clinically indicated) of up to 26 weeks, followed by a taper phase of up to 2 weeks.

    Number of subjects in period 1
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Started
    92
    93
    98
    Received treatment
    91
    93
    97
    Completed
    66
    63
    59
    Not completed
    26
    30
    39
         Protocol deviation
    2
    1
    2
         Medication error/not related to AE
    -
    1
    -
         Started study but did not receive study treatment
    1
    -
    1
         Not specified
    3
    2
    4
         Adverse event, non-fatal
    5
    8
    12
         Insufficient clinical response
    3
    2
    -
         No longer willing to participate
    7
    7
    13
         Lost to follow-up
    5
    9
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo/DVS-SR
    Reporting group description
    Participants received placebo tablets in previous study B2061032 and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    DVS-SR, low dose/DVS-SR
    Reporting group description
    Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    DVS-SR, high dose/DVS-SR
    Reporting group description
    Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR Total
    Number of subjects
    92 93 98 283
    Age, Customized
    Units: Participants
        2 to 11 years
    28 26 33 87
        12 to 17 years
    64 67 65 196
    Gender, Male/Female
    Units: Participants
        Female
    43 52 61 156
        Male
    49 41 37 127

    End points

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    End points reporting groups
    Reporting group title
    Placebo/DVS-SR
    Reporting group description
    Participants received placebo tablets in previous study B2061032 and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    DVS-SR, low dose/DVS-SR
    Reporting group description
    Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    DVS-SR, high dose/DVS-SR
    Reporting group description
    Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Subject analysis set title
    Combination Group
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.

    Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)

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    End point title
    Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) [1]
    End point description
    A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period. Analysis population included all participants who received at least 1 dose of study drug in study B2061030.
    End point type
    Primary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this primary endpoint
    End point values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Number of subjects analysed
    91
    93
    97
    Units: Percentage of participants
        number (not applicable)
    78
    73.1
    71.1
    No statistical analyses for this end point

    Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)

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    End point title
    Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) [2]
    End point description
    A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period. Analysis population included all participants who received at least 1 dose of study drug in study B2061030.
    End point type
    Primary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this primary endpoint
    End point values
    Combination Group
    Number of subjects analysed
    281
    Units: Percentage of participants
        number (not applicable)
    74
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases

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    End point title
    Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
    End point description
    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. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Number of subjects analysed
    63
    57
    56
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -6.79 ± 12.05
    -10.72 ± 10.8
    -8.57 ± 13.01
    No statistical analyses for this end point

    Secondary: 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)

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    End point title
    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)
    End point description
    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. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Combination Group
    Number of subjects analysed
    176
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -8.63 ± 12.03
    No statistical analyses for this end point

    Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases

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    End point title
    Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
    End point description
    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. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Number of subjects analysed
    63
    57
    56
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.02 ± 1.18
    -1.44 ± 1.12
    -0.7 ± 1.37
    No statistical analyses for this end point

    Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)

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    End point title
    Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
    End point description
    The 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. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Combination Group
    Number of subjects analysed
    176
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.05 ± 1.26
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    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
    End point description
    The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & impact of 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 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Number of subjects analysed
    63
    57
    56
    Units: Percentage of participants
        number (not applicable)
    87.3
    94.7
    89.3
    No statistical analyses for this end point

    Secondary: 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)

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    End point title
    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)
    End point description
    The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & impact of 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, & 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 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, & were available for evaluation.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Combination Group
    Number of subjects analysed
    176
    Units: Percentage of participants
        number (not applicable)
    90.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases

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    End point title
    Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
    End point description
    The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & 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 to assess improvement in a patient's illness relative to baseline. Scores range from 1 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Number of subjects analysed
    63
    57
    56
    Units: Percentage of participants
    number (not applicable)
        Week 26: Very much improved
    54
    73.7
    53.6
        Week 26: Much improved
    33.3
    21.1
    35.7
        Week 26: Minimally improved
    9.5
    5.3
    10.7
        Week 26: No change
    1.6
    0
    0
        Week 26: Minimally worse
    1.6
    0
    0
        Week 26: Much worse
    0
    0
    0
        Week 26: Very much worse
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)

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    End point title
    Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
    End point description
    The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates 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 to assess improvement in a patient's illness relative to baseline. Scores range from 1 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I score of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants with a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, & were available for evaluation.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Combination Group
    Number of subjects analysed
    176
    Units: Percentage of participants
    number (not applicable)
        Week 26: Very much improved
    60.2
        Week 26: Much improved
    30.1
        Week 26: Minimally improved
    8.5
        Week 26: No change
    0.6
        Week 26: Minimally worse
    0.6
        Week 26: Much worse
    0
        Week 26: Very much worse
    0
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    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
    End point description
    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. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Placebo/DVS-SR DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Number of subjects analysed
    63
    57
    56
    Units: Percentage of participants
        number (not applicable)
    73
    89.5
    75
    No statistical analyses for this end point

    Secondary: 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)

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    End point title
    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)
    End point description
    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. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
    End point type
    Secondary
    End point timeframe
    From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
    End point values
    Combination Group
    Number of subjects analysed
    176
    Units: Percentage of participants
        number (not applicable)
    79
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Placebo/DVS-SR
    Reporting group description
    Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    Combination Group
    Reporting group description
    Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    DVS-SR, low dose/DVS-SR
    Reporting group description
    Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Reporting group title
    DVS-SR, high dose/DVS-SR
    Reporting group description
    Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

    Serious adverse events
    Placebo/DVS-SR Combination Group DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 91 (4.40%)
    13 / 281 (4.63%)
    6 / 93 (6.45%)
    3 / 97 (3.09%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    0 / 93 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 281 (0.36%)
    0 / 93 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 281 (0.71%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Initial insomnia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 281 (0.36%)
    0 / 93 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyromania
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    2 / 91 (2.20%)
    5 / 281 (1.78%)
    1 / 93 (1.08%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 281 (1.07%)
    2 / 93 (2.15%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide threat
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 281 (0.36%)
    0 / 93 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Ketoacidosis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 281 (0.36%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Placebo/DVS-SR Combination Group DVS-SR, low dose/DVS-SR DVS-SR, high dose/DVS-SR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 91 (65.93%)
    175 / 281 (62.28%)
    57 / 93 (61.29%)
    58 / 97 (59.79%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    8 / 91 (8.79%)
    20 / 281 (7.12%)
    4 / 93 (4.30%)
    8 / 97 (8.25%)
         occurrences all number
    12
    29
    7
    10
    Ligament sprain
         subjects affected / exposed
    3 / 91 (3.30%)
    3 / 281 (1.07%)
    0 / 93 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Investigations
    Weight increased
         subjects affected / exposed
    5 / 91 (5.49%)
    14 / 281 (4.98%)
    4 / 93 (4.30%)
    5 / 97 (5.15%)
         occurrences all number
    5
    14
    4
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 91 (4.40%)
    15 / 281 (5.34%)
    6 / 93 (6.45%)
    5 / 97 (5.15%)
         occurrences all number
    4
    18
    7
    7
    Headache
         subjects affected / exposed
    12 / 91 (13.19%)
    45 / 281 (16.01%)
    16 / 93 (17.20%)
    17 / 97 (17.53%)
         occurrences all number
    19
    79
    29
    31
    Psychomotor hyperactivity
         subjects affected / exposed
    3 / 91 (3.30%)
    4 / 281 (1.42%)
    1 / 93 (1.08%)
    0 / 97 (0.00%)
         occurrences all number
    4
    5
    1
    0
    Somnolence
         subjects affected / exposed
    10 / 91 (10.99%)
    14 / 281 (4.98%)
    3 / 93 (3.23%)
    1 / 97 (1.03%)
         occurrences all number
    10
    14
    3
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 91 (3.30%)
    6 / 281 (2.14%)
    0 / 93 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    3
    6
    0
    3
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 91 (0.00%)
    5 / 281 (1.78%)
    2 / 93 (2.15%)
    3 / 97 (3.09%)
         occurrences all number
    0
    5
    2
    3
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    3 / 91 (3.30%)
    6 / 281 (2.14%)
    1 / 93 (1.08%)
    2 / 97 (2.06%)
         occurrences all number
    3
    6
    1
    2
    Depression
         subjects affected / exposed
    1 / 91 (1.10%)
    8 / 281 (2.85%)
    3 / 93 (3.23%)
    4 / 97 (4.12%)
         occurrences all number
    1
    8
    3
    4
    Initial insomnia
         subjects affected / exposed
    5 / 91 (5.49%)
    6 / 281 (2.14%)
    0 / 93 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    5
    6
    0
    1
    Insomnia
         subjects affected / exposed
    7 / 91 (7.69%)
    17 / 281 (6.05%)
    6 / 93 (6.45%)
    4 / 97 (4.12%)
         occurrences all number
    8
    18
    6
    4
    Irritability
         subjects affected / exposed
    3 / 91 (3.30%)
    14 / 281 (4.98%)
    4 / 93 (4.30%)
    7 / 97 (7.22%)
         occurrences all number
    3
    15
    5
    7
    Self injurious behaviour
         subjects affected / exposed
    0 / 91 (0.00%)
    4 / 281 (1.42%)
    3 / 93 (3.23%)
    1 / 97 (1.03%)
         occurrences all number
    0
    4
    3
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 91 (4.40%)
    13 / 281 (4.63%)
    1 / 93 (1.08%)
    8 / 97 (8.25%)
         occurrences all number
    4
    17
    1
    12
    Constipation
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 281 (1.07%)
    0 / 93 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    0
    3
    0
    3
    Diarrhoea
         subjects affected / exposed
    2 / 91 (2.20%)
    8 / 281 (2.85%)
    1 / 93 (1.08%)
    5 / 97 (5.15%)
         occurrences all number
    3
    9
    1
    5
    Nausea
         subjects affected / exposed
    4 / 91 (4.40%)
    21 / 281 (7.47%)
    11 / 93 (11.83%)
    6 / 97 (6.19%)
         occurrences all number
    5
    25
    11
    9
    Vomiting
         subjects affected / exposed
    6 / 91 (6.59%)
    12 / 281 (4.27%)
    2 / 93 (2.15%)
    4 / 97 (4.12%)
         occurrences all number
    7
    16
    2
    7
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 91 (1.10%)
    4 / 281 (1.42%)
    0 / 93 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    1
    4
    0
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 91 (2.20%)
    5 / 281 (1.78%)
    3 / 93 (3.23%)
    0 / 97 (0.00%)
         occurrences all number
    2
    5
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 91 (3.30%)
    7 / 281 (2.49%)
    2 / 93 (2.15%)
    2 / 97 (2.06%)
         occurrences all number
    4
    10
    2
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 91 (4.40%)
    7 / 281 (2.49%)
    2 / 93 (2.15%)
    1 / 97 (1.03%)
         occurrences all number
    4
    7
    2
    1
    Increased appetite
         subjects affected / exposed
    0 / 91 (0.00%)
    4 / 281 (1.42%)
    3 / 93 (3.23%)
    1 / 97 (1.03%)
         occurrences all number
    0
    4
    3
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 91 (3.30%)
    6 / 281 (2.14%)
    2 / 93 (2.15%)
    1 / 97 (1.03%)
         occurrences all number
    3
    6
    2
    1
    Gastroenteritis viral
         subjects affected / exposed
    7 / 91 (7.69%)
    16 / 281 (5.69%)
    3 / 93 (3.23%)
    6 / 97 (6.19%)
         occurrences all number
    7
    16
    3
    6
    Nasopharyngitis
         subjects affected / exposed
    9 / 91 (9.89%)
    21 / 281 (7.47%)
    4 / 93 (4.30%)
    8 / 97 (8.25%)
         occurrences all number
    10
    23
    5
    8
    Otitis media
         subjects affected / exposed
    3 / 91 (3.30%)
    5 / 281 (1.78%)
    1 / 93 (1.08%)
    1 / 97 (1.03%)
         occurrences all number
    3
    5
    1
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 91 (1.10%)
    5 / 281 (1.78%)
    1 / 93 (1.08%)
    3 / 97 (3.09%)
         occurrences all number
    1
    5
    1
    3
    Sinusitis
         subjects affected / exposed
    1 / 91 (1.10%)
    8 / 281 (2.85%)
    2 / 93 (2.15%)
    5 / 97 (5.15%)
         occurrences all number
    1
    9
    2
    6
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 91 (4.40%)
    16 / 281 (5.69%)
    10 / 93 (10.75%)
    2 / 97 (2.06%)
         occurrences all number
    5
    19
    11
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2011
    Clarified that no repackaging or labeling of the study drug containers that obscured the Pfizer label was permitted at the sites. Deleted investigational procedures from the prohibited treatment list. Text revised to clarify participants who were required to sign an informed consent document were those reaching the age of majority rather than reaching the age of 18 years. Addition of methaqualone to the urine drug screen testing list. Added the 10 mg/day dose blister card to the table in Appendix 1 of the protocol.
    22 May 2013
    Updates/clarifications to Schedule of Activities. Adult studies in introduction revised. Combined & clarified efficacy endpoints. Permitted omission of taper& exclusion of extension. Updated study duration. Inclusion criteria: 2: changed “legally acceptable representative” to “legal guardian”; 4, 5 & 6: clarified contraception requirements. Exclusion criteria: 1: deleted “potential child or adolescent”; 2: renamed “study drug” to “investigational product”; 4: clarified exclusion of participants requiring prohibited medication; 6: clarified history of suicide behavior exclusion since last visit, added risk assessment; 7: clarified suicidal ideation exclusion since last visit, added risk assessment. Added sections on sponsor qualified medical personnel, rater qualifications, & medication errors. Revised text for storage requirements. Clarified examples & use of permitted & prohibited concomitant treatments. Clarified review of results prior to randomisation. Clarified participant withdrawal, process for lost to follow-up, & added risk assessment. Clarified assessments for AEs/SAEs, vital signs, pregnancy testing, microscopic analysis, urine drug screen & comprehensive psychiatric evaluation. Revised text on guidance materials & clarified rater requirements/training. Added requirements for risk assessment & discontinuation following C-SSRS; evaluations. Clarified AE follow-up, serious versus non-serious AEs, timeframes for reporting, AE examples, defined significant disability/incapacity, protocol-specific SAEs, Hy’s Law criteria, causality assessment definition, reporting of exposures in utero, & source for AE information. Clarified the DMC responsibilities, Pfizer record retention policy, participant de-identification information, informed consent process & Pfizer communication of results. Added vendor information. Deleted End of Trial in a Member State section. Added table of diagnostician & rater requirements.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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