A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents (ADHD LIFE)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00447278
First received: March 12, 2007
Last updated: April 22, 2010
Last verified: April 2010

March 12, 2007
April 22, 2010
March 2007
March 2009   (final data collection date for primary outcome measure)
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Mean change in the achievement domain of the Child Health and Illness Profile – Child Edition, Parent Report Form (CHIP-CE PRF)at 6 months.
Complete list of historical versions of study NCT00447278 on ClinicalTrials.gov Archive Site
  • Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
    CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
  • Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance) [ Time Frame: Baseline, 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
  • Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) [ Time Frame: Baseline, 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0="never or not at all", 1="sometimes or somewhat", 2="often or much", 3="very often or very much"). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).
  • Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv) [ Time Frame: Baseline, 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.
  • Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S) [ Time Frame: Baseline, 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
  • Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years) [ Time Frame: Baseline, 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
  • Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years) [ Time Frame: Baseline, 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
  • Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.
  • Mean change in the achievement domain of the CHIP-CE PRF at 4 months.
  • Change in the CHIP-CE PRF total score and domains (satisfaction, comfort, resilience and risk avoidance)at 4 and 6 months.
  • Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)at 4 and 6 months.
  • ADHD-RS-IV Parent:Inv at 4 and 6 months.
  • CGI-ADHD-S at 4 and 6 months.
  • Change in the CHIP-CE CRF for children (6-11 years) and CHIP-AE for adolescents (>11-17 years)at 4 and 6 months.
Not Provided
Not Provided
 
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Atomoxetine
    0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
    Other Names:
    • LY139603
    • Strattera
  • Drug: Other standard therapy for ADHD
    Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
  • Experimental: Atomoxetine
    0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
    Intervention: Drug: Atomoxetine
  • Active Comparator: OEST
    Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
    Intervention: Drug: Other standard therapy for ADHD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
399
July 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion criteria:

    • 6 to 16 years old
    • Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
    • Pharmacological naïve
    • Normal intelligence as assessed by investigator
    • Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion Criteria:

  • Exclusion criteria

    • History of bipolar disorder, any history of psychosis or autism spectrum disorder
    • History of any seizure disorder
    • Significant prior or current medical conditions
    • History of alcohol or drug abuse within the past 3 months
    • Patients who are taking concurrently any of the excluded medications in the study.
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Ireland,   Italy,   Mexico,   Norway,   Spain,   Turkey,   United Kingdom
 
NCT00447278
11576, B4Z-EW-LYDY
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP