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  
Number of Participants  
[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  
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  
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  
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  
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  
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  
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  
[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.



  Outcome Measures
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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


  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.


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.  


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00447278     History of Changes
Other Study ID Numbers: 11576, B4Z-EW-LYDY
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