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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
Results First Received: February 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Atomoxetine
Drug: Other standard therapy for ADHD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study consisted of a 1 week screening (Period I); 6 months open-label (Period II); Optional additional 6 month open-label extension (Period III).

Reporting Groups
  Description
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
OEST Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Participant Flow for 2 periods

Period 1:   Period II (6 Month Open-Label)
    Atomoxetine   OEST
STARTED   199   200 
Received at Least One Dose of Study Drug   199   199 [1] 
COMPLETED   157   171 
NOT COMPLETED   42   29 
Adverse Event                7                3 
Lost to Follow-up                0                4 
Protocol Violation                10                7 
Withdrawal by Subject                1                3 
Physician Decision                4                1 
Lack of Efficacy                11                1 
Parent/Guardian Decision                9                10 
[1] 1 patient withdrew due to parent/guardian decision prior to receiving study drug.

Period 2:   Period III (Optional 6 Month Extension)
    Atomoxetine   OEST
STARTED   139 [1]   155 [2] 
COMPLETED   109   140 
NOT COMPLETED   30   15 
Adverse Event                2                2 
Lost to Follow-up                2                2 
Protocol Violation                6                1 
Withdrawal by Subject                4                1 
Physician Decision                1                1 
Lack of Efficacy                4                0 
Parent/Guardian Decision                11                8 
[1] 18 choose not to enter this optional period.
[2] 16 choose not to enter this optional period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
OEST Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
Total Total of all reporting groups

Baseline Measures
   Atomoxetine   OEST   Total 
Overall Participants Analyzed 
[Units: Participants]
 199   199   398 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.2  (2.57)   9.4  (2.64)   9.3  (2.60) 
Gender 
[Units: Participants]
     
Female   41   41   82 
Male   158   158   316 
Race/Ethnicity, Customized 
[Units: Participants]
     
African   0   2   2 
Caucasian   180   181   361 
East Asian   2   1   3 
Hispanic   17   15   32 
Region of Enrollment 
[Units: Participants]
     
France   32   32   64 
Mexico   11   12   23 
Belgium   23   23   46 
Spain   61   58   119 
Ireland   3   2   5 
Turkey   23   24   47 
Norway   10   10   20 
United Kingdom   16   18   34 
Italy   20   20   40 
Kiddie Schedule for Affective Disorders - Affective Disorder [1] 
[Units: Participants]
     
0 Affective Disorders   189   189   378 
1 Affective Disorder   2   1   3 
Missing Information   8   9   17 
[1] The Kiddie-SADS-Present and Lifetime Version is an instrument completed through a semi-structured diagnostic interview designed to assess current and lifetime history of psychopathology in children and adolescents according to Diagnostic and Statistical Manual of Mental Disorders Third Edition, Revision (DSM-III-R) and DSM Fourth Edition (DSM-IV) criteria. The ‘Summary Lifetime Diagnoses Checklist’ aggregates diagnoses-related data to make a final decision as to the presence or absence of the evaluated condition/disease.
Kiddie Schedule for Affective Disorders - Anxiety Disorder [1] 
[Units: Participants]
     
0 Anxiety Disorders   176   173   349 
1 Anxiety Disorder   11   18   29 
2 Anxiety Disorders   4   6   10 
3 Anxiety Disorders   2   0   2 
4 Anxiety Disorders   1   0   1 
Missing Information   5   2   7 
[1] The Kiddie-SADS-Present and Lifetime Version is an instrument completed through a semi-structured diagnostic interview designed to assess current and lifetime history of psychopathology in children and adolescents according to Diagnostic and Statistical Manual of Mental Disorders Third Edition, Revision (DSM-III-R) and DSM Fourth Edition (DSM-IV) criteria. The ‘Summary Lifetime Diagnoses Checklist’ aggregates diagnoses-related data to make a final decision as to the presence or absence of the evaluated condition/disease.
Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes [1] 
[Units: Participants]
     
Combined ADHD Subtype   156   156   312 
Hyperactive/Impulsive ADHD Subtype   4   7   11 
Inattentive ADHD Subtype   39   36   75 
[1] The Kiddie-SADS-Present and Lifetime Version is an instrument completed through a semi-structured diagnostic interview designed to assess current and lifetime history of psychopathology in children and adolescents according to Diagnostic and Statistical Manual of Mental Disorders Third Edition, Revision (DSM-III-R) and DSM Fourth Edition (DSM-IV) criteria. The ‘Summary Lifetime Diagnoses Checklist’ aggregates diagnoses-related data to make a final decision as to the presence or absence of the evaluated condition/disease.
Kiddie Schedule for Affective Disorders - Conduct Disorder [1] 
[Units: Participants]
     
Yes (currently have the disorder)   13   10   23 
Yes, but not present (had disorder in the past)   2   2   4 
No (never had the disorder)   184   187   371 
[1] The Kiddie-SADS-Present and Lifetime Version is an instrument completed through a semi-structured diagnostic interview designed to assess current and lifetime history of psychopathology in children and adolescents according to Diagnostic and Statistical Manual of Mental Disorders Third Edition, Revision (DSM-III-R) and DSM Fourth Edition (DSM-IV) criteria. The ‘Summary Lifetime Diagnoses Checklist’ aggregates diagnoses-related data to make a final decision as to the presence or absence of the evaluated condition/disease.
Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder [1] 
[Units: Participants]
     
Yes (currently have the disorder)   79   73   152 
Yes, but not present (had disorder in the past)   2   4   6 
No (never had the disorder)   118   122   240 
[1] The Kiddie-SADS-Present and Lifetime Version is an instrument completed through a semi-structured diagnostic interview designed to assess current and lifetime history of psychopathology in children and adolescents according to Diagnostic and Statistical Manual of Mental Disorders Third Edition, Revision (DSM-III-R) and DSM Fourth Edition (DSM-IV) criteria. The ‘Summary Lifetime Diagnoses Checklist’ aggregates diagnoses-related data to make a final decision as to the presence or absence of the evaluated condition/disease.
Kiddie Schedule for Affective Disorders - Tic Disorder [1] 
[Units: Participants]
     
0 Tic Disorders   176   178   354 
1 Tic Disorder   13   14   27 
2 Tic Disorders   2   2   4 
3 Tic Disorders   3   3   6 
Missing Information   5   2   7 
[1] The Kiddie-SADS-Present and Lifetime Version is an instrument completed through a semi-structured diagnostic interview designed to assess current and lifetime history of psychopathology in children and adolescents according to Diagnostic and Statistical Manual of Mental Disorders Third Edition, Revision (DSM-III-R) and DSM Fourth Edition (DSM-IV) criteria. The ‘Summary Lifetime Diagnoses Checklist’ aggregates diagnoses-related data to make a final decision as to the presence or absence of the evaluated condition/disease.
Age at Onset of Attention-Deficit/Hyperactivity Disorder (ADHD) 
[Units: Years]
Mean (Standard Deviation)
 4.3  (1.88)   4.2  (1.91)   4.2  (1.89) 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 138.8  (14.59)   140.1  (15.71)   139.4  (15.16) 
Time Since Onset of ADHD 
[Units: Years]
Mean (Standard Deviation)
 5.0  (2.65)   5.2  (2.97)   5.1  (2.81) 
Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 37.5  (14.30)   37.6  (13.35)   37.5  (13.82) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain   [ Time Frame: Baseline, 4 months, 12 months ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores   [ Time Frame: Baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00447278     History of Changes
Other Study ID Numbers: 11576
B4Z-EW-LYDY ( Other Identifier: Eli Lilly and Company )
Study First Received: March 12, 2007
Results First Received: February 24, 2010
Last Updated: April 22, 2010
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Belgium: Institutional Review Board