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    Clinical Trial Results:
    A 26-week, International, Multicenter, Open-label Phase IIIb Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents with Bipolar I Disorder and Adolescents with Schizophrenia

    Summary
    EudraCT number
    2004-000751-42
    Trial protocol
    DE  
    Global end of trial date
    10 Jul 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1441C00150
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00227305
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    1 MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Heather Wray, Seroquel Medical Science Director, MD, AstraZeneca, 46 0 31 706 4082, AZTrial_Results_Posting@astrazeneca.com
    Scientific contact
    Heather Wray, Seroquel Medical Science Director, MD, AstraZeneca, 46 0 31 706 4082, AZTrial_Results_Posting@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
    10 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the safety and tolerability of quetiapine in children and adolescent patients with bipolar I disorder and in adolescents with schizophrenia by: 1) the incidence and nature of overall AEs; 2) the rate of patient withdrawal due to AEs; 3) the changes from the open-label baseline to Week 26 in clinical laboratory results, vital signs, weight, body mass index, ECG and physical exam findings; 4) the changes from open-labe baseline to Week 26 in the Simpson-Angus Scale total score, the Barnes Akathisia Scale global score and the Abnormal Involuntary Movement Scale total score.
    Protection of trial subjects
    The final study protocol, including the final version of the Informed Consent Form was approved or given a favorable opinion in writing by an Institutional Review Board or Independent Ethics Committee as appropriate. The principal investigator was responsible for informing the IRB or IEC of any amendment to the protocol and re-approved in accorndance with local requirements. 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 that are consistent with International Conference on Harmonization (ICH)/ Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics. 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, and possible risks and benefits of the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Aug 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: 248
    Country: Number of subjects enrolled
    Puerto Rico: 4
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Russian Federation: 34
    Country: Number of subjects enrolled
    Serbia: 20
    Country: Number of subjects enrolled
    Ukraine: 20
    Country: Number of subjects enrolled
    India: 5
    Country: Number of subjects enrolled
    Malaysia: 6
    Country: Number of subjects enrolled
    Philippines: 30
    Country: Number of subjects enrolled
    South Africa: 6
    Worldwide total number of subjects
    380
    EEA total number of subjects
    7
    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)
    46
    Adolescents (12-17 years)
    323
    Adults (18-64 years)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Enrollment was contingent on completing one of 2 short term efficacy studies, recruitment period August 2004 through July 2007 at 59 international clinical research sites

    Pre-assignment
    Screening details
    Required to have completed one feeder study, either bipolar mania study D1441C00149 or schizophrenia study D1441C00112 and be willing to participate in a 26 week open label study and be between the ages of 10 and 18 years at the time of consent for this study, initial titration to maintain blind in feeder study

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

    Arms
    Arm title
    Quetiapine
    Arm description
    Quetiapine 400mg/day to 800mg/day
    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
    Titrated from single 50 mg dose to target dose of 400-800 mg/day

    Number of subjects in period 1
    Quetiapine
    Started
    380
    Drug received
    380
    Completed
    237
    Not completed
    143
         Study specific discontinuation
             12
         Physician decision
             3
         MOVED OUT OF AREA
             3
         Lack of efficacy
             7
         NECESSITY OF USING ANTI DEPRESSANT
             1
         Adverse event, non-fatal
             40
         Consent withdrawn by subject
             42
         LEAVING TOWN FOR 6 WEEKS
             1
         PERIOD SHORTENED FROM 6 wks to 4 wks
             1
         Lost to follow-up
             33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quetiapine
    Reporting group description
    Quetiapine 400mg/day to 800mg/day

    Reporting group values
    Quetiapine Total
    Number of subjects
    380 380
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    46 46
        Adolescents (12-17 years)
    323 323
        Adults (18-64 years)
    11 11
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.4 ± 2.2 -
    Gender, Male/Female
    Units: Participants
        Female
    154 154
        Male
    226 226
    Age, Customized
    Units: Subjects
        10 - 12 years
    87 87
        13 - 18 years
    293 293
    Study Specific Characteristic
    Units: Subjects
        Bipolar
    205 205
        Schizophrenia
    175 175
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of experimental drug

    Subject analysis sets values
    Safety Analysis Set
    Number of subjects
    380
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    46
        Adolescents (12-17 years)
    323
        Adults (18-64 years)
    11
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.4 ± 2.2
    Gender, Male/Female
    Units: Participants
        Female
    154
        Male
    226
    Age, Customized
    Units: Subjects
        10 - 12 years
    87
        13 - 18 years
    293
    Study Specific Characteristic
    Units: Subjects
        Bipolar
    205
        Schizophrenia
    175

    End points

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    End points reporting groups
    Reporting group title
    Quetiapine
    Reporting group description
    Quetiapine 400mg/day to 800mg/day

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of experimental drug

    Primary: Incidence and nature of adverse events (AEs)

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    End point title
    Incidence and nature of adverse events (AEs) [1]
    End point description
    Number of participants that had AE which occurred from first dose date to last dose date + 30 days.
    End point type
    Primary
    End point timeframe
    from open label to week 26+ 30 days
    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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    380
    Units: Participants
    321
    No statistical analyses for this end point

    Primary: Number of patients withdrawn due to AEs.

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    End point title
    Number of patients withdrawn due to AEs. [2]
    End point description
    Number of subjects who withdrew from the study due to AEs.
    End point type
    Primary
    End point timeframe
    during 26 weeks of treatment
    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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    380
    Units: Participants
    37
    No statistical analyses for this end point

    Primary: Changes in laboratory test results (Prolactin)

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    End point title
    Changes in laboratory test results (Prolactin) [3]
    End point description
    Clinical important shift to high prolactin from open-label (OL) baseline to week 26. High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male.
    End point type
    Primary
    End point timeframe
    Duration of study participation
    Notes
    [3] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    380
    Units: Participants
    19
    No statistical analyses for this end point

    Primary: Categorical Change from baseline in Barnes Akathisia Rating Scale (BARS) global score

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    End point title
    Categorical Change from baseline in Barnes Akathisia Rating Scale (BARS) global score [4]
    End point description
    Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse. Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score.
    End point type
    Primary
    End point timeframe
    26 weeks of treatment
    Notes
    [4] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    373
    Units: Participants
    11
    No statistical analyses for this end point

    Primary: Categorical Change from OL baseline to week 26 in Simpson-Angus Scale (SAS)total score

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    End point title
    Categorical Change from OL baseline to week 26 in Simpson-Angus Scale (SAS)total score [5]
    End point description
    Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse). Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score.
    End point type
    Primary
    End point timeframe
    OL baseline to week 26
    Notes
    [5] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    373
    Units: Participants
    34
    No statistical analyses for this end point

    Primary: Change from baseline in weight

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    End point title
    Change from baseline in weight [6]
    End point description
    Number with 7% or more increase (without adjustment for normal growth)
    End point type
    Primary
    End point timeframe
    26 weeks of treatment
    Notes
    [6] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    373
    Units: Participants
    134
    No statistical analyses for this end point

    Primary: Change from baseline in supine pulse

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    End point title
    Change from baseline in supine pulse [7]
    End point description
    Change from OL baseline to week 26 in supine pulse (bpm)
    End point type
    Primary
    End point timeframe
    OL baseline to week 26
    Notes
    [7] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    375
    Units: bpm
        arithmetic mean (standard deviation)
    0.8 ± 14.75
    No statistical analyses for this end point

    Primary: Change from OL baseline in supine systolic BP.

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    End point title
    Change from OL baseline in supine systolic BP. [8]
    End point description
    Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
    End point type
    Primary
    End point timeframe
    OL baseline to Week 26
    Notes
    [8] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    375
    Units: mmHg
        arithmetic mean (standard deviation)
    1.7 ± 11.52
    No statistical analyses for this end point

    Primary: Change from OL baseline in supine diastolic BP.

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    End point title
    Change from OL baseline in supine diastolic BP. [9]
    End point description
    Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
    End point type
    Primary
    End point timeframe
    OL baseline to Week 26
    Notes
    [9] - 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: descriptive statistics employed only, no statistical comparisons were employed in this safety extension study
    End point values
    Quetiapine
    Number of subjects analysed
    375
    Units: mmHg
        arithmetic mean (standard deviation)
    1.3 ± 9.22
    No statistical analyses for this end point

    Secondary: Changes in Tanner stage

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    End point title
    Changes in Tanner stage
    End point description
    Category shift in Tanner stage. Number of subjects who experienced the change is presented. Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
    End point type
    Secondary
    End point timeframe
    Change from OL baseline to week 26 in the Tanner stage
    End point values
    Quetiapine
    Number of subjects analysed
    373
    Units: Participants
    70
    No statistical analyses for this end point

    Secondary: Change from baseline in Children's Global Assessment Scale (CGAS) score

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    End point title
    Change from baseline in Children's Global Assessment Scale (CGAS) score
    End point description
    Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).
    End point type
    Secondary
    End point timeframe
    OL Baseline to Week 26
    End point values
    Quetiapine
    Number of subjects analysed
    320
    Units: units on a scale
        arithmetic mean (standard deviation)
    7 ± 13.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Other AE module includes adverse events which occurred before first dose date to last dose date + 30 days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Quetiapine
    Reporting group description
    Quetiapine 400mg/day to 800mg/day

    Serious adverse events
    Quetiapine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 380 (12.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertensive Crisis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Physical Assault
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Drug Toxicity
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Overdose
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 380 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocarditis Post Infection
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Hypertension
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Irritability
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Abnormal Behaviour
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Agitation
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aggression
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    4 / 380 (1.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Bipola Disorder
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    12 / 380 (3.16%)
         occurrences causally related to treatment / all
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    Disinhibition
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Delusion
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hostility
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hallucitnation Auditory
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mania
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perceptual Alteration Paroxysmal
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyschotic Disorder
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 380 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Restlessness
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    8 / 380 (2.11%)
         occurrences causally related to treatment / all
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia, Paraniod Type
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide Attempt
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacterial Infection
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 380 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Amoebiasis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis Staphylococcal
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal Infection
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper Respiratory Tract Infection
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Typhoid Fever
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 380 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Quetiapine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    340 / 380 (89.47%)
    Cardiac disorders
    TACHYCARDIA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    25 / 380 (6.58%)
         occurrences all number
    31
    Respiratory, thoracic and mediastinal disorders
    NASAL CONGESTION
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    20 / 380 (5.26%)
         occurrences all number
    21
    Nervous system disorders
    DIZZINESS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    26 / 380 (6.84%)
         occurrences all number
    38
    HEADACHE
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    43 / 380 (11.32%)
         occurrences all number
    102
    SOMNOLENCE
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    115 / 380 (30.26%)
         occurrences all number
    140
    SEDATION
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    72 / 380 (18.95%)
         occurrences all number
    80
    Psychiatric disorders
    AGITATION
    alternative dictionary used: MedDRA 10.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    26 / 380 (6.84%)
         occurrences all number
    37
    INSOMNIA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    43 / 380 (11.32%)
         occurrences all number
    52
    IRRITABILITY
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    23 / 380 (6.05%)
         occurrences all number
    29
    Gastrointestinal disorders
    DRY MOUTH
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    35 / 380 (9.21%)
         occurrences all number
    35
    FATIGUE
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    20 / 380 (5.26%)
         occurrences all number
    23
    NAUSEA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    39 / 380 (10.26%)
         occurrences all number
    48
    WEIGHT INCREASED
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    65 / 380 (17.11%)
         occurrences all number
    66
    VOMITING
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    43 / 380 (11.32%)
         occurrences all number
    53
    Metabolism and nutrition disorders
    INCREASED APPETITE
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    76 / 380 (20.00%)
         occurrences all number
    78
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    27 / 380 (7.11%)
         occurrences all number
    29

    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 Assessment to monitor for signs of emergent depression and to evaluate suicidal ideation

    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.
    No comparator group, open label treatment, duration only 26 weeks - not long enough to assess full impact on growth and development
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