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    Clinical Trial Results:
    A randomised, double-blind, placebo controlled, parallel group comparison study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder- MRP

    Summary
    EudraCT number
    		 2015-004905-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Feb 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2016
    First version publication date
    01 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    112487
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Apr 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Mar 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 56
    Worldwide total number of subjects
    56
    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)
    5
    Adolescents (12-17 years)
    51
    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
    		 This study consisted of 3 phases: a 2-week placebo run-in phase, an 8-week treatment phase, and a 0- to 3-week taper phase. In the run-in phase, placebo was administered once daily for 2 weeks. In the treatment phase, paroxetine or placebo was orally administered once daily for 8 weeks. In the taper phase, the dose was gradually reduced.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matched placebo to Paroxetine 20 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet once a day after evening meal

    Investigational medicinal product name
    Matched placebo to Paroxetine 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 tablets once a day after evening meal

    Arm title
    		 Paroxetine
    Arm description
    		 Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paroxetine 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 or 2 tablets once daily after evening meal

    Investigational medicinal product name
    Paroxetine 20 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet once a day after evening meal

    Number of subjects in period 1
    		Placebo Paroxetine
    Started
    27
    29
    Completed
    24
    25
    Not completed
    3
    4
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    2
    1
         Lost to follow-up
    -
    1
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).

    Reporting group title
    Paroxetine
    Reporting group description
    		 Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.

    Reporting group values
    		 Placebo Paroxetine Total
    Number of subjects
    		 27 29
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 14.8 ± 2.62 14.4 ± 1.99 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 18 16 34
        Male
    		 9 13 22
    Race/Ethnicity, Customized
    Units: Subjects
        Asian - Japanese Heritage
    		 27 29 56

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).

    Reporting group title
    Paroxetine
    Reporting group description
    		 Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.

    Primary: Change from Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8

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    End point title
    		 Change from Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8
    End point description
    The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline. Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset.
    End point type
    Primary
    End point timeframe
    Baseline and Week 8
    End point values
    		 Placebo Paroxetine
    Number of subjects analysed
    27 [1]
    29 [2]
    Units: scores on a scale
        least squares mean (standard error)
    -11.9 ± 2.54
    -16.5 ± 2.45
    Notes
    [1] - Full Analysis Set.
    [2] - Full Analysis Set.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean difference was estimated as paroxetine minus placebo.
    Comparison groups
    Paroxetine v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.198
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 2.5

    Secondary: Change from Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6

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    End point title
    		 Change from Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6
    End point description
    The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder. The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline. The analysis was performed on the observed case dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1, 2, 3, 4, and 6
    End point values
    		 Placebo Paroxetine
    Number of subjects analysed
    27 [3]
    29 [4]
    Units: scores on a scale
    least squares mean (standard error)
        Week 1, n=27, 29
    -4.6 ± 1.1
    -5.4 ± 1.06
        Week 2, n=26, 29
    -4.9 ± 1.56
    -8.8 ± 1.48
        Week 3, n=24, 28
    -10.6 ± 1.9
    -12 ± 1.76
        Week 4, n=25, 27
    -12.5 ± 2.24
    -14.6 ± 2.15
        Week 6, n=24, 26
    -14.2 ± 2.21
    -15.7 ± 2.12
    Notes
    [3] - Full Analysis Set.
    [4] - Full Analysis Set.
    No statistical analyses for this end point

    Secondary: Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8

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    End point title
    		 Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8
    End point description
    CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 3, 4, 6, and 8
    End point values
    		 Placebo Paroxetine
    Number of subjects analysed
    27 [5]
    29 [6]
    Units: participants
        Week 1, n=27, 29
    4
    4
        Week 2, n=26, 29
    4
    7
        Week 3, n=24, 28
    7
    9
        Week 4, n=25, 27
    13
    12
        Week 6, n=24, 26
    12
    13
        Week 8 (OC), n=24, 25
    11
    14
        Week 8 (LOCF), n=27, 29
    11
    15
    Notes
    [5] - Full Analysis Set.
    [6] - Full Analysis Set.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8

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    End point title
    		 Change from Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8
    End point description
    CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1, 2, 3, 4, 6, and 8
    End point values
    		 Placebo Paroxetine
    Number of subjects analysed
    27 [7]
    29 [8]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 1, n=27, 29
    -0.1 ± 0.32
    -0.2 ± 0.41
        Week 2, n=26, 29
    -0.1 ± 0.48
    -0.5 ± 0.69
        Week 3, n=24, 28
    -0.3 ± 0.62
    -0.6 ± 0.57
        Week 4, n=25, 27
    -0.5 ± 0.82
    -0.7 ± 0.76
        Week 6, n=24, 26
    -0.5 ± 0.66
    -0.8 ± 0.82
        Week 8 (OC), n=24, 25
    -0.5 ± 0.72
    -1 ± 0.89
        Week 8 (LOCF), n=27, 29
    -0.4 ± 0.75
    -0.9 ± 0.88
    Notes
    [7] - Full Analysis Set.
    [8] - Full Analysis Set.
    No statistical analyses for this end point

    Secondary: Plasma paroxetine concentrations at 12 hours and 24 hours after administration of study drug at Week 8 or Withdrawal

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    End point title
    		 Plasma paroxetine concentrations at 12 hours and 24 hours after administration of study drug at Week 8 or Withdrawal [9]
    End point description
    Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8). All participants who received paroxetine and in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).
    End point type
    Secondary
    End point timeframe
    Week 8 or Withdrawal (up to Week 8)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting on a subset of the arms that are contained in the baseline period.
    End point values
    		 Paroxetine
    Number of subjects analysed
    18
    Units: nanograms per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        paroxetine 10 mg, 12 hours, n=4
    4.4683 ± 2.16507
        paroxetine 10 mg, 24 hours, n=3
    8.9713 ± 7.81518
        paroxetine 20 mg, 12 hours, n=1
    49.582 ± 0
        paroxetine 20 mg, 24 hours, n=3
    18.2713 ± 9.78765
        paroxetine 30 mg, 12 hours, n=2
    64.4285 ± 23.34372
        paroxetine 40 mg, 12 hours, n=3
    108.9133 ± 9.01693
        paroxetine 40 mg, 24 hours, n=2
    67.9855 ± 4.08778
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected during the treatment (8 weeks at maximum) and taper phases (3 weeks at maximum). SAEs were also collected during the follow-up phase (2 weeks after the last dose of investigational product).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).

    Reporting group title
    Paroxetine
    Reporting group description
    		 Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.

    Serious adverse events
    		 Placebo Paroxetine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Paroxetine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 27 (33.33%)
    9 / 29 (31.03%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 27 (14.81%)
    6 / 29 (20.69%)
         occurrences all number
    4
    6
    Influenza
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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