Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder with or without comorbid conditions

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2005-005701-32
    Trial protocol
    		 IT  
    Global end of trial date
    06 Oct 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Jul 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Correction needed to Full Data Set
    Summary report(s)
    		 EudraCT Full Data Set Results PDF

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B4Z-IT-LYDS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00320528
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 9867, Trial Alias: B4Z-IT-LYDS
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLILLY,
    Scientific contact
    Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Oct 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Please Note: The Agency is aware of a bug when posting the summary of the clinical trial results: the order in which the arms/reporting groups are provided may not be maintained when the results are viewed online, downloaded as a PDF or downloaded as a XML. This inconsistency may exist in other areas like subject disposition, end points, baseline characteristics etc. where the reporting groups are referenced. Please see attached results summary for correctly reported baseline characteristics data. Main Objective: This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 2006
    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
    Italy: 269
    Worldwide total number of subjects
    269
    EEA total number of subjects
    269
    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)
    187
    Adolescents (12-17 years)
    82
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 No text entered.

    Pre-assignment
    Screening details
    		 Study Period I was a 3-day screening period. Study Period II was 12 weeks long. Study Period III was an optional additional 12 week open-label extension. Results are presented for Period II (patients who received at least one dose of study drug).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pure ADHD (Period II)
    Arm description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    .5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Arm title
    		 ADHD+Internalizing Disorders (Period II)
    Arm description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine:... more 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeksless
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Arm title
    		 ADHD+Externalizing Disorders (Period II)
    Arm description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    .5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Number of subjects in period 1
    		Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Started
    98
    41
    130
    Received at Least One Dose of Study Drug
    97
    38
    128
    Completed
    87
    31
    108
    Not completed
    11
    10
    22
         Parent/Caregiver Decision
    8
    3
    11
         Consent withdrawn by subject
    -
    1
    1
         Adverse event, non-fatal
    3
    4
    8
         Entry Criteria Exclusion
    -
    2
    2
    Period 2
    Period 2 title
    Study Period III
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Pure ADHD (Period III)
    Arm description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    .5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Arm title
    		 ADHD+Internalizing Disorders (Period III)
    Arm description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    .5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Arm title
    		 ADHD+Externalizing Disorders (Period III)
    Arm description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    .5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Number of subjects in period 2
    		Pure ADHD (Period III) ADHD+Internalizing Disorders (Period III) ADHD+Externalizing Disorders (Period III)
    Started
    87
    31
    108
    Completed
    0
    0
    2
    Not completed
    87
    31
    106
         Parent/Caregiver Decision
    14
    3
    11
         Consent withdrawn by subject
    1
    -
    -
         Atomoxetine Commercially Available
    68
    25
    90
         Physician decision
    -
    1
    2
         Adverse event, non-fatal
    1
    -
    -
         Withdrawal by Subject
    -
    1
    2
         Sponsor Decision
    -
    -
    1
         Protocol Violation
    -
    1
    -
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    2
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pure ADHD (Period II)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Reporting group title
    ADHD+Internalizing Disorders (Period II)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine:... more 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeksless

    Reporting group title
    ADHD+Externalizing Disorders (Period II)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Reporting group values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II) Total
    Number of subjects
    		 98 41 130 269
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.12 ( 2.51 ) 10.42 ( 2.41 ) 10 ( 2.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 3 9 26
        Male
    		 83 35 119 237
        Not Recorded
    		 1 3 2 6
    Region of Enrollment
    Units: Subjects
        Italy
    		 98 41 130 269
    Race/Ethnicity
    Units: Subjects
        Caucasian
    		 90 36 124 250
        Hispanic
    		 1 2 2 5
        African
    		 3 0 0 3
        Native American
    		 1 0 2 3
        East Asian
    		 2 0 0 2
        Not Recorded
    		 1 3 2 6
    Child Health and Illness Profile - Child Edition (CHIP-CE) - Achievement Domain (N=96, N=33, N=121)
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
    Units: T-Score
        arithmetic mean (standard deviation)
    		 29.27 ( 7.89 ) 27.72 ( 7.73 ) 25.83 ( 7.6 ) -
    Child Health and Illness Profile - Child Edition (CHIP-CE) - Satisfaction Domain (N=96, N=24, N=122)
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
    Units: T-Score
        arithmetic mean (standard deviation)
    		 39.26 ( 13.89 ) 30.11 ( 14.83 ) 31.69 ( 14.78 ) -
    Child Health and Illness Profile - Child Edition (CHIP-CE) - Comfort Domain (N=96, N=35, N=122)
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
    Units: T-Score
        arithmetic mean (standard deviation)
    		 51.31 ( 9.4 ) 46.76 ( 12.28 ) 44.74 ( 9.38 ) -
    Child Health and Illness Profile - Child Edition (CHIP-CE) - Resilience Domain (N=96, N=34, N=123)
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
    Units: T-Score
        arithmetic mean (standard deviation)
    		 39.34 ( 10.15 ) 34.96 ( 10.89 ) 31.4 ( 11.85 ) -
    Child Health and Illness Profile - Child Edition (CHIP-CE) - Risk Avoidance (N=96, N=33, N=121)
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
    Units: T-Score
        arithmetic mean (standard deviation)
    		 32.03 ( 9.7 ) 30.48 ( 12.29 ) 22.85 ( 12 ) -
    Children's Depression Rating Scale-Revised (CDRS-R)
    Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 37.93 ( 12.26 ) 43.76 ( 13.48 ) 43.06 ( 13.69 ) -
    Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S)
    Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 4.64 ( 0.79 ) 4.97 ( 0.79 ) 4.98 ( 0.78 ) -
    Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S) Oppositional
    A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 5.97 ( 4.93 ) 4.97 ( 4.66 ) 8.62 ( 4.83 ) -
    Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S) Cognitive Problems
    A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 7.86 ( 3.73 ) 7.68 ( 3.8 ) 7.96 ( 3.61 ) -
    Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S) Hyperactivity
    A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 11.38 ( 6.09 ) 12.03 ( 5.21 ) 14.67 ( 5.15 ) -
    Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S) ADHD Index
    A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 22.14 ( 6.86 ) 22.94 ( 6.01 ) 25.18 ( 6.07 ) -
    Pediatric Anxiety Rating Scale (PARS)
    The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 2.5 ( 2.67 ) 7.5 ( 5.68 ) 4.67 ( 5.12 ) -
    Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV) Inattention Subscale (N=97, N=38, N=127)
    The SNAP-IV is a 26-item scale that includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is score on 0 to 3 scale (0 = “Not at All”, 1 = “Just a Little”, 2 = “Pretty Much”, 3 = “Very Much”). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperactivity/impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). Combined type (inattention + hyperactivity/impulsivity) scores range from 0-54.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 20.28 ( 4.19 ) 21.03 ( 3.72 ) 21.87 ( 3.48 ) -
    SNAP-IV Hyperactivity/Impulsivity Subscale (N=97, N=38)
    The SNAP-IV is a 26-item scale that includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is score on 0 to 3 scale (0 = “Not at All”, 1 = “Just a Little”, 2 = “Pretty Much”, 3 = “Very Much”). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperactivity/impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). Combined type (inattention + hyperactivity/impulsivity) scores range from 0-54.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 17.21 ( 6.1 ) 19.66 ( 5.54 ) 21.04 ( 3.48 ) -
    Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV) Combined Type Subscale (N=97, N=38, N=127)
    The SNAP-IV is a 26-item scale that includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is score on 0 to 3 scale (0 = “Not at All”, 1 = “Just a Little”, 2 = “Pretty Much”, 3 = “Very Much”). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperactivity/impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). Combined type (inattention + hyperactivity/impulsivity) scores range from 0-54.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 37.48 ( 7.78 ) 40.68 ( 7.87 ) 42.91 ( 5.51 ) -
    Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV) Oppositional Subscale (N=97, N=38, N=127)
    The SNAP-IV is a 26-item scale that includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is score on 0 to 3 scale (0 = “Not at All”, 1 = “Just a Little”, 2 = “Pretty Much”, 3 = “Very Much”). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperactivity/impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). Combined type (inattention + hyperactivity/impulsivity) scores range from 0-54.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 10.15 ( 4.54 ) 12.32 ( 4.67 ) 17.99 ( 3.57 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pure ADHD (Period II)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Reporting group title
    ADHD+Internalizing Disorders (Period II)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine:... more 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeksless

    Reporting group title
    ADHD+Externalizing Disorders (Period II)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
    Reporting group title
    Pure ADHD (Period III)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Reporting group title
    ADHD+Internalizing Disorders (Period III)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Reporting group title
    ADHD+Externalizing Disorders (Period III)
    Reporting group description
    		 Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

    Primary: 1: Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain

    		 Close Top of page
    End point title
    		 1: Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
    End point description
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
    End point type
    Primary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    83 [1]
    28 [2]
    97 [3]
    Units: T-Score
        arithmetic mean (confidence interval 95%)
    2.65 (0.93 to 4.37)
    0.51 (-1.38 to 2.39)
    3.89 (2.22 to 5.57)
    Notes
    [1] - Number of patients with baseline and at least one nonmissing post-baseline measurement.
    [2] - Number of patients with baseline and at least one nonmissing post-baseline measurement.
    [3] - Number of patients with baseline and at least one nonmissing post-baseline measurement.
    Statistical analysis title
    		 Statistical Analysis for End Point 1
    Comparison groups
    ADHD+Internalizing Disorders (Period II) v ADHD+Externalizing Disorders (Period II) v Pure ADHD (Period II)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 LOCF analysis
    Confidence interval

    Secondary: 2: Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)

    		 Close Top of page
    End point title
    		 2: Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
    End point description
    Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    90
    33
    111
    Units: units on a scale
    arithmetic mean (confidence interval 95%)
        Inattention Subscale
    -5.88 (-7.25 to -5.13)
    -5.52 (-7.34 to -3.69)
    -7.58 (-8.69 to -6.46)
        Hyperactivity/Impulsivity Subscale
    -12.1 (-13.9 to -10.3)
    -5.67 (-7.41 to -3.92)
    -8.08 (-9.09 to -7.07)
        Combined Type (ADHD) Subscale
    -6.19 (-6.97 to -4.78)
    -11.2 (-14.4 to -7.92)
    -15.7 (-17.6 to -13.7)
    No statistical analyses for this end point

    Secondary: 3: Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)

    		 Close Top of page
    End point title
    		 3: Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
    End point description
    Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    88
    32
    112
    Units: units on a scale
        arithmetic mean (confidence interval 95%)
    -1.23 (-1.46 to -0.99)
    -1.63 (-1.99 to -1.26)
    -1.42 (-1.63 to -1.21)
    No statistical analyses for this end point

    Secondary: 4: Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains

    		 Close Top of page
    End point title
    		 4: Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
    End point description
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    97
    38
    128
    Units: T-Score
    arithmetic mean (confidence interval 95%)
        Satisfaction Domain (N=88, N=31, N=105)
    2.14 (-0.06 to 4.34)
    0.81 (-3.33 to 4.95)
    3.78 (1.18 to 6.39)
        Comfort Domain (N=86, N=28, N=103)
    1.01 (-0.88 to 2.9)
    5.72 (1.24 to 10.19)
    4.94 (3.14 to 6.73)
        Resilience Domain (N=87, N=30, N=106)
    1.21 (-0.85 to 3.27)
    2.18 (-1.31 to 5.67)
    3.07 (1.1 to 5.03)
        Risk Avoidance Domain (N=82, N=28, N=94)
    4.72 (2.93 to 6.51)
    5.7 (1.96 to 9.45)
    9.88 (7.88 to 11.88)
    No statistical analyses for this end point

    Secondary: 5: Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)

    		 Close Top of page
    End point title
    		 5: Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)
    End point description
    The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    89
    33
    112
    Units: units on a scale
        arithmetic mean (confidence interval 95%)
    -0.18 (-0.7 to 0.34)
    -1.88 (-3.4 to -0.36)
    -1.18 (-1.9 to -0.46)
    No statistical analyses for this end point

    Secondary: 6: Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)

    		 Close Top of page
    End point title
    		 6: Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)
    End point description
    Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    97
    38
    128
    Units: units on a scale
        arithmetic mean (confidence interval 95%)
    -1.6 (-3.54 to 0.34)
    -2.56 (-6.38 to 1.25)
    -3.13 (-4.64 to -1.62)
    No statistical analyses for this end point

    Secondary: 7: Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale

    		 Close Top of page
    End point title
    		 7: Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale
    End point description
    Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    90
    33
    111
    Units: units on a scale
        arithmetic mean (confidence interval 95%)
    -2.01 (-2.86 to -1.16)
    -2.12 (-3.95 to -0.29)
    -5.54 (-6.43 to -4.65)
    No statistical analyses for this end point

    Secondary: 8: Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)

    		 Close Top of page
    End point title
    		 8: Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
    End point description
    Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    26
    10
    30
    Units: units on a scale
    arithmetic mean (standard deviation)
        Category A - Baseline
    32.73 ( 11.42 )
    38.33 ( 10.32 )
    38.13 ( 8.3 )
        Category A - Change from Baseline
    -11.4 ( 9.88 )
    -10.4 ( 11.55 )
    -11.6 ( 9.5 )
        Category B - Baseline
    4.04 ( 4.25 )
    6 ( 5.62 )
    10.8 ( 5.41 )
        Category B - Change from Baseline
    -0.73 ( 2.92 )
    -0.6 ( 5.83 )
    -5.57 ( 5.58 )
        Category C- Baseline
    7.92 ( 4.77 )
    10.5 ( 3.72 )
    15.6 ( 5.24 )
        Category C - Change from Baseline
    -0.88 ( 3.85 )
    -1.4 ( 6.15 )
    -5.47 ( 5.51 )
        Category D- Baseline
    4.73 ( 3.14 )
    9.2 ( 3.58 )
    8.37 ( 3.54 )
        Category D - Change from Baseline
    -0.58 ( 3.09 )
    -1.7 ( 3.65 )
    -2.97 ( 3.67 )
        Category E- Baseline
    3.58 ( 4 )
    7.6 ( 7.85 )
    3.63 ( 3.16 )
        Category E - Change from Baseline
    -0.38 ( 4.01 )
    -4.5 ( 8.72 )
    -1.3 ( 2.35 )
        Category F- Baseline
    1.19 ( 1.27 )
    2.6 ( 1.43 )
    1.2 ( 1.37 )
        Category F - Change from Baseline
    -0.58 ( 0.81 )
    -1.4 ( 1.43 )
    -0.53 ( 1.25 )
        Category G- Baseline
    2.27 ( 3.5 )
    4.5 ( 5.25 )
    2.1 ( 2.63 )
        Category G - Change from Baseline
    -0.46 ( 2.49 )
    -3.2 ( 4.71 )
    -0.97 ( 2.4 )
        Category H- Baseline
    0.73 ( 1.28 )
    1.6 ( 2.27 )
    1.7 ( 1.74 )
        Category H - Change from Baseline
    -0.38 ( 1.2 )
    0.2 ( 2.86 )
    -0.67 ( 1.69 )
        Category I- Baseline
    1 ( 1.92 )
    3.2 ( 3.65 )
    2.13 ( 2.22 )
        Category I - Change from Baseline
    -0.19 ( 0.8 )
    -1.3 ( 3.89 )
    -0.93 ( 1.7 )
        Category J- Baseline
    0.42 ( 0.99 )
    0.4 ( 0.97 )
    0.5 ( 0.78 )
        Category J - Change from Baseline
    0 ( 0.69 )
    -0.3 ( 0.67 )
    -0.23 ( 0.43 )
        Category K- Baseline
    3.73 ( 3.99 )
    4.9 ( 2.85 )
    4.23 ( 4.05 )
        Category K - Change from Baseline
    -1.04 ( 2.9 )
    -1 ( 3.5 )
    -1.6 ( 3.5 )
        Category L- Baseline
    3.54 ( 4.68 )
    5.1 ( 5 )
    6.03 ( 5.02 )
        Category L - Change from Baseline
    -1.08 ( 3.46 )
    -0.2 ( 6.03 )
    -1.97 ( 4.3 )
        Category M- Baseline
    0.73 ( 1.22 )
    1.3 ( 2.06 )
    0.5 ( 1.41 )
        Category M - Change from Baseline
    0.15 ( 1.08 )
    -0.1 ( 3.21 )
    0.3 ( 1.39 )
        Category N- Baseline
    1.31 ( 1.54 )
    2.2 ( 3.05 )
    2.3 ( 1.84 )
        Category N - Change from Baseline
    -0.38 ( 1.7 )
    -0.9 ( 2.23 )
    -0.8 ( 1.49 )
        Category O- Baseline
    0.23 ( 0.71 )
    0.3 ( 0.95 )
    0.53 ( 0.97 )
        Category O - Change from Baseline
    0.15 ( 0.37 )
    -0.2 ( 0.63 )
    -0.13 ( 0.51 )
    No statistical analyses for this end point

    Secondary: 9: Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)

    		 Close Top of page
    End point title
    		 9: Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
    End point description
    The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    58
    22
    78
    Units: units on a scale
    arithmetic mean (standard deviation)
        Category A - Baseline
    34 ( 10.43 )
    36 ( 9.32 )
    38.95 ( 8.68 )
        Category A - Change from Baseline
    -10.6 ( 9.76 )
    -9.68 ( 9.54 )
    -12.7 ( 12.06 )
        Category B - Baseline
    9.29 ( 4.72 )
    11.05 ( 4.13 )
    15.65 ( 4.4 )
        Category B - Change from Baseline
    -2.12 ( 3.88 )
    -1.14 ( 5.25 )
    -3.76 ( 5.56 )
        Category C - Baseline
    2.1 ( 2.44 )
    2.23 ( 2.25 )
    4.63 ( 3.69 )
        Category C - Change from Baseline
    -0.88 ( 2.11 )
    -0.05 ( 3.06 )
    -1.99 ( 3.17 )
        Category D - Baseline
    5.83 ( 3.37 )
    8.23 ( 3.96 )
    7.41 ( 3.94 )
        Category D - Change from Baseline
    -0.84 ( 3.16 )
    -2.23 ( 3.01 )
    -1.63 ( 3.86 )
        Category E - Baseline
    2.07 ( 1.87 )
    2.09 ( 1.95 )
    2.79 ( 2.69 )
        Category E - Change from Baseline
    -0.38 ( 1.9 )
    -0.41 ( 1.75 )
    -0.85 ( 2.43 )
        Category F - Baseline
    0.48 ( 0.86 )
    0.32 ( 0.57 )
    0.91 ( 1.35 )
        Category F - Change from Baseline
    -0.17 ( 0.94 )
    -0.14 ( 0.64 )
    -0.24 ( 1.28 )
        Category G - Baseline
    3.02 ( 2.7 )
    4.05 ( 2.79 )
    3.51 ( 3.3 )
        Category G - Change from Baseline
    -0.62 ( 2.4 )
    -0.91 ( 2 )
    -0.46 ( 2.52 )
        Category H - Baseline
    3.66 ( 4.14 )
    4.64 ( 4.02 )
    4.45 ( 4.39 )
        Category H - Change from Baseline
    -1.1 ( 2.21 )
    -1.09 ( 2.93 )
    -1.54 ( 4.31 )
        Category I - Baseline
    2.76 ( 1.85 )
    2.77 ( 1.38 )
    2.94 ( 1.93 )
        Category I - Change from Baseline
    -0.03 ( 1.83 )
    -0.45 ( 1.47 )
    -0.32 ( 1.75 )
        Category J - Baseline
    3.92 ( 3.98 )
    5.58 ( 6.05 )
    5.22 ( 4.47 )
        Category J - Change from Baseline
    -1.34 ( 3.64 )
    -0.83 ( 2.61 )
    -1.55 ( 4.34 )
    No statistical analyses for this end point

    Secondary: 10: Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)

    		 Close Top of page
    End point title
    		 10: Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
    End point description
    A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Pure ADHD (Period II) ADHD+Internalizing Disorders (Period II) ADHD+Externalizing Disorders (Period II)
    Number of subjects analysed
    60
    15
    53
    Units: units on a scale
    arithmetic mean (confidence interval 95%)
        Oppositional
    -1.42 (-2.22 to -0.61)
    1.07 (-0.33 to 2.46)
    -2.35 (-3.55 to -1.15)
        Cognitive Problems
    -1.08 (-1.72 to -0.45)
    -0.47 (-1.74 to 0.8)
    -0.94 (-1.77 to -0.11)
        Hyperactivity
    -2.87 (-4.04 to -1.69)
    -2.34 (-4.8 to 0.11)
    -4.09 (-5.52 to -2.67)
        ADHD Index
    -4.96 (-6.36 to -3.52)
    -3.6 (-6.65 to -0.55)
    -6.62 (-8.59 to -4.65)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    B4Z-IT-LYDS
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Pure ADHD
    Reporting group description
    		 -

    Reporting group title
    ADHD plus internalizing disorders
    Reporting group description
    		 -

    Reporting group title
    ADHD plus externalizing disorders
    Reporting group description
    		 -

    Serious adverse events
    		 Pure ADHD ADHD plus internalizing disorders ADHD plus externalizing disorders
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 38 (0.00%)
    2 / 128 (1.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    facial bones fracture
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
         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
    idiosyncratic drug reaction
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    vomiting
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 38 (0.00%)
    0 / 128 (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
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
    		 Pure ADHD ADHD plus internalizing disorders ADHD plus externalizing disorders
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 97 (72.16%)
    28 / 38 (73.68%)
    87 / 128 (67.97%)
    Investigations
    weight decreased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    11 / 97 (11.34%)
    1 / 38 (2.63%)
    12 / 128 (9.38%)
         occurrences all number
    15
    1
    15
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    20 / 97 (20.62%)
    10 / 38 (26.32%)
    26 / 128 (20.31%)
         occurrences all number
    34
    17
    35
    somnolence
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    22 / 97 (22.68%)
    11 / 38 (28.95%)
    34 / 128 (26.56%)
         occurrences all number
    23
    15
    44
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    5 / 97 (5.15%)
    6 / 38 (15.79%)
    7 / 128 (5.47%)
         occurrences all number
    6
    6
    7
    fatigue
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    5 / 97 (5.15%)
    0 / 38 (0.00%)
    2 / 128 (1.56%)
         occurrences all number
    5
    0
    3
    irritability
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 97 (4.12%)
    6 / 38 (15.79%)
    12 / 128 (9.38%)
         occurrences all number
    4
    6
    16
    pyrexia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 97 (3.09%)
    0 / 38 (0.00%)
    8 / 128 (6.25%)
         occurrences all number
    3
    0
    8
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    9 / 97 (9.28%)
    8 / 38 (21.05%)
    18 / 128 (14.06%)
         occurrences all number
    13
    9
    32
    abdominal pain upper
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    5 / 97 (5.15%)
    6 / 38 (15.79%)
    12 / 128 (9.38%)
         occurrences all number
    5
    8
    17
    constipation
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 97 (2.06%)
    2 / 38 (5.26%)
    1 / 128 (0.78%)
         occurrences all number
    2
    2
    1
    diarrhoea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 38 (5.26%)
    3 / 128 (2.34%)
         occurrences all number
    3
    2
    3
    nausea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    12 / 97 (12.37%)
    10 / 38 (26.32%)
    26 / 128 (20.31%)
         occurrences all number
    17
    19
    36
    vomiting
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    13 / 97 (13.40%)
    6 / 38 (15.79%)
    15 / 128 (11.72%)
         occurrences all number
    23
    13
    20
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 97 (3.09%)
    0 / 38 (0.00%)
    8 / 128 (6.25%)
         occurrences all number
    3
    0
    10
    Psychiatric disorders
    aggression
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 97 (4.12%)
    1 / 38 (2.63%)
    9 / 128 (7.03%)
         occurrences all number
    5
    1
    9
    Infections and infestations
    gastroenteritis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 97 (2.06%)
    2 / 38 (5.26%)
    0 / 128 (0.00%)
         occurrences all number
    2
    2
    0
    Metabolism and nutrition disorders
    anorexia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    24 / 97 (24.74%)
    11 / 38 (28.95%)
    33 / 128 (25.78%)
         occurrences all number
    26
    15
    39
    decreased appetite
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    11 / 97 (11.34%)
    7 / 38 (18.42%)
    14 / 128 (10.94%)
         occurrences all number
    13
    7
    20

    More information

    		 Close Top of page

    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.
    The original intent was to also calculate change and 95% confidence intervals at end of Period III; however, due to low number of patients completing Period III, variations from baseline (LOCF), are not suitable for further analysis or description.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 05:47:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA