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    Clinical Trial Results:
    A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Immediate-release Tablets in Daily Doses of 400 mg and 800 mg Compared with Placebo in the Treatment of Adolescents with Schizophrenia.

    Summary
    EudraCT number
    		 2004-000750-22
    Trial protocol
    		 DE  
    Global end of trial date
    14 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2016
    First version publication date
    13 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1441C00112
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00090324
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Heather Wray, Research Physician, AstraZeneca, 46 0 31 706 4082, Heather.Wray@Astrazeneca.com
    Scientific contact
    Heather Wray, Research Physician, AstraZeneca, 46 0 31 706 4082, Heather.Wray@Astrazeneca.com
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Heather Wray, Research Physician, AstraZeneca, 46 0 31 706 4082, Heather.Wray@Astrazeneca.com
    Scientific contact
    Heather Wray, Research Physician, AstraZeneca, 46 0 31 706 4082, heather.wray@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000324-PIP01-08
    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
    14 Feb 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare the efficacy of 2 doses of quetiapine (400 mg/day and 800 mg/day) with that of placebo in the treatment of schizophrenia in adolescent patients as assessed by the change from baseline to Day 42 in the Positive and Negative Syndrome Scale (PANSS) total score (primary outcome variable).
    Protection of trial subjects
    The final study protocol, including the final version of the Informed Consent Form (ICF), was approved or given a favorable opinion in writing by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) as appropriate. The Principal Investigator was responsible for informing the IRB or IEC of any amendment to the protocol in accordance with local requirements. The Principal Investigator was also responsible for providing the IRB with reports of any serious adverse drug reactions from any other study conducted with the investigational product. Progress reports and notifications of serious adverse drug reactions were provided to the IRB or IEC according to local regulations and guidelines. The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with Internation Conference on Harmonization (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioeithics. The Principal Investigator at each center ensured that both the patient (assent) and the parent or legal guardian (consent) were given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 62
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Russian Federation: 39
    Country: Number of subjects enrolled
    Serbia: 26
    Country: Number of subjects enrolled
    Ukraine: 27
    Country: Number of subjects enrolled
    India: 8
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Philippines: 31
    Country: Number of subjects enrolled
    South Africa: 6
    Country: Number of subjects enrolled
    Germany: 1
    Worldwide total number of subjects
    222
    EEA total number of subjects
    10
    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)
    0
    Adolescents (12-17 years)
    222
    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
    		 This multicenter study was conducted between 1 October 2004 and 20 June 2007. 268 patients were enrolled from one of 43 international centers

    Pre-assignment
    Screening details
    		 This study had a 28 day washout period and a 6-week double-blind treatment period where patients were randomized to quetiapine 400 mg/day, 800 mg/day or placebo.

    Pre-assignment period milestones
    Number of subjects started
    		 268 [1]
    Number of subjects completed
    		 222

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 42
    Reason: Number of subjects
    		 Patient Moved: 2
    Reason: Number of subjects
    		 Adverse event, non-fatal: 2
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period is 268, which includes 46 patients who were initially found eligible but were not enrolled into the study. The worldwide number enrolled in the trial is 222 which is the number of subjects who were actually entered into the study.
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Quetiapine 400 mg/day
    Arm description
    		 Quetiapine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quetiapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once a day

    Arm title
    		 Quetiapine 800 mg/day
    Arm description
    		 Quetiapine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quetiapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet once a day

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    plaacebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one tablet once a day

    Number of subjects in period 1
    		Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Started
    73
    74
    75
    Completed
    56
    61
    47
    Not completed
    17
    13
    28
         Consent withdrawn by subject
    3
    3
    8
         Adverse event, non-fatal
    5
    7
    2
         Reasons Unrelated to Treatment
    3
    1
    1
         Lost to follow-up
    -
    -
    2
         Protocol deviation
    6
    2
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quetiapine 400 mg/day
    Reporting group description
    		 Quetiapine

    Reporting group title
    Quetiapine 800 mg/day
    Reporting group description
    		 Quetiapine

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo Total
    Number of subjects
    		 73 74 75 222
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 73 74 75 222
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 15.5 ( 1.3 ) 15.5 ( 1.3 ) 15.3 ( 1.4 ) -
    Gender, Male/Female
    Number
    Units: Participants
        Female
    		 30 30 31 91
        Male
    		 43 44 44 131
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 15 13 12 40
        Black or African American
    		 7 9 11 27
        White
    		 45 44 48 137
        Unknown or Not Reported
    		 6 8 4 18

    End points

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    End points reporting groups
    Reporting group title
    Quetiapine 400 mg/day
    Reporting group description
    		 Quetiapine

    Reporting group title
    Quetiapine 800 mg/day
    Reporting group description
    		 Quetiapine

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: PANSS total score

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    End point title
    		 PANSS total score
    End point description
    Change
    End point type
    Primary
    End point timeframe
    Baseline to 42 days
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    54
    55
    43
    Units: Rating Scale
        least squares mean (standard error)
    -27.3 ( 2.6 )
    -28.4 ( 1.8 )
    -19.2 ( 3 )
    Statistical analysis title
    		 Change from Baseline in PANSS Total Score
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.043
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.1
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4
    Statistical analysis title
    		 Change from Baseline in PANSS Total Score
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 -2.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5

    Secondary: Response at day 42

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    End point title
    		 Response at day 42
    End point description
    Percentage of patients with >= 30% reduction from baseline in PANSS total score
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    54
    55
    43
    Units: Participants
    28
    22
    17
    Statistical analysis title
    		 Percent Responders
    Statistical analysis description
    30% decrease from baseline to end of study in PANSS total score
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.125
    Method
    		 GEE
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 4.13
    Statistical analysis title
    		 Percentage Responders
    Statistical analysis description
    30% reduction in PANSS total score from baseline to end of study
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.675
    Method
    		 GEE
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 2.87

    Secondary: PANSS postive symptom subscale

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    End point title
    		 PANSS postive symptom subscale
    End point description
    Change
    End point type
    Secondary
    End point timeframe
    Baseline to Day 42
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    54
    55
    43
    Units: Rating Scale
        least squares mean (standard error)
    -8.6 ( 0.7 )
    -9.3 ( 0.6 )
    -6.5 ( 0.9 )
    Statistical analysis title
    		 PANSS Positive Symptom Subscale
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 PANSS Positive Symptom Subscale
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.075
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1

    Secondary: PANSS negative symptom subscale

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    End point title
    		 PANSS negative symptom subscale
    End point description
    Change
    End point type
    Secondary
    End point timeframe
    Baseline to Day 42
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    54
    55
    43
    Units: Rating Scale
        least squares mean (standard error)
    -6.4 ( 0.8 )
    -6.2 ( 0.6 )
    -5.1 ( 0.7 )
    Statistical analysis title
    		 Change in PANSS Negative Symptom Subscale
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.239
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 Change in PANSS Negative Symptom Subscale
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.245
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1

    Secondary: CGI Severity of Illness total score

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    End point title
    		 CGI Severity of Illness total score
    End point description
    Change
    End point type
    Secondary
    End point timeframe
    Baseline to Day 42
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    55
    55
    42
    Units: Number
        least squares mean (standard error)
    -1.2 ( 0.1 )
    -1.3 ( 0.1 )
    -0.8 ( 0.2 )
    Statistical analysis title
    		 Change in CGI Severity of Illness Score
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Statistical analysis title
    		 Change in CGI Severity of Illness score
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.104
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Secondary: CGI Global Improvement score

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    End point title
    		 CGI Global Improvement score
    End point description
    Number of patients with improvement
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    55
    55
    43
    Units: Participants
    33
    31
    18
    Statistical analysis title
    		 CGI Global Improvement
    Statistical analysis description
    Percent of patients with improvement
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 GEE
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 6
    Statistical analysis title
    		 CGI Global Improvement
    Statistical analysis description
    Percent of patients with improvement
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 GEE
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 6.1

    Secondary: CGAS total score

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    End point title
    		 CGAS total score
    End point description
    Change
    End point type
    Secondary
    End point timeframe
    Baseline to Day 42
    End point values
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Number of subjects analysed
    65
    63
    65
    Units: Rating scale
        least squares mean (standard error)
    13 ( 1.5 )
    14.9 ( 1.5 )
    9.9 ( 1.5 )
    Statistical analysis title
    		 CGAS total score
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 800 mg/day v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 9.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.1
    Statistical analysis title
    		 CGAS total score
    Statistical analysis description
    Change from baseline to end of study
    Comparison groups
    Quetiapine 400 mg/day v Placebo
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.139
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 7.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety Analysis Set (Number of Patients at Risk: Quetiapine 400 mg/day=73; Quetiapine 800 mg/day=74; Placebo=75, Total=222
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9
    Reporting groups
    Reporting group title
    Quetiapine 400 mg/day
    Reporting group description
    		 Quetiapine

    Reporting group title
    Quetiapine 800 mg/day
    Reporting group description
    		 Quetiapine

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 73 (5.48%)
    5 / 74 (6.76%)
    4 / 75 (5.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Schizophrenia
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 74 (1.35%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucinations, visual
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 74 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 74 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Verbal Abuse
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Irritabililty
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delusions
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypersensitivity
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 74 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Wound abscess
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Amoebiasis
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Quetiapine 400 mg/day Quetiapine 800 mg/day Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 73 (79.45%)
    55 / 74 (74.32%)
    45 / 75 (60.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    20 / 73 (27.40%)
    22 / 74 (29.73%)
    5 / 75 (6.67%)
         occurrences all number
    22
    23
    5
    Headache
         subjects affected / exposed
    6 / 73 (8.22%)
    16 / 74 (21.62%)
    14 / 75 (18.67%)
         occurrences all number
    13
    32
    28
    Dizziness
         subjects affected / exposed
    6 / 73 (8.22%)
    11 / 74 (14.86%)
    4 / 75 (5.33%)
         occurrences all number
    7
    15
    7
    Insomnia
         subjects affected / exposed
    9 / 73 (12.33%)
    7 / 74 (9.46%)
    17 / 75 (22.67%)
         occurrences all number
    12
    19
    25
    Agitation
         subjects affected / exposed
    6 / 73 (8.22%)
    6 / 74 (8.11%)
    10 / 75 (13.33%)
         occurrences all number
    15
    20
    10
    Sedation
         subjects affected / exposed
    4 / 73 (5.48%)
    4 / 74 (5.41%)
    3 / 75 (4.00%)
         occurrences all number
    5
    4
    3
    Anxiety
         subjects affected / exposed
    4 / 73 (5.48%)
    3 / 74 (4.05%)
    5 / 75 (6.67%)
         occurrences all number
    5
    3
    13
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 73 (5.48%)
    4 / 74 (5.41%)
    3 / 75 (4.00%)
         occurrences all number
    4
    4
    4
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    3 / 73 (4.11%)
    7 / 74 (9.46%)
    1 / 75 (1.33%)
         occurrences all number
    3
    7
    1
    Increased appetite
         subjects affected / exposed
    3 / 73 (4.11%)
    5 / 74 (6.76%)
    3 / 75 (4.00%)
         occurrences all number
    3
    5
    3
    Nausea
         subjects affected / exposed
    3 / 73 (4.11%)
    4 / 74 (5.41%)
    13 / 75 (17.33%)
         occurrences all number
    3
    6
    15
    Vomiting
         subjects affected / exposed
    3 / 73 (4.11%)
    4 / 74 (5.41%)
    6 / 75 (8.00%)
         occurrences all number
    4
    4
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2006
    Addition of CDRS-R

    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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