An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00192023
First received: September 12, 2005
Last updated: December 9, 2009
Last verified: December 2009
Results First Received: May 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Interventions: Drug: atomoxetine 0.5 mg/kg/day
Drug: placebo
Drug: atomoxetine 1.2 mg/kg/day
Drug: atomoxetine 1.2-1.4 mg/kg/day

  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 Period I=Screening. Study Period II=Standardized behavioral management program for parents (156 entered, 17 discontinued). Study Period III=Double-Blind (randomization). Two patients did not have post-baseline values for the primary endpoint and were not included in Baseline or efficacy analyses. Study Period IV=Optional open-label phase.

Reporting Groups
  Description
Atomoxetine atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
Placebo placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.

Participant Flow for 2 periods

Period 1:   Period III - Double-Blind
    Atomoxetine     Placebo  
STARTED     107     32  
COMPLETED     100 [1]   32 [2]
NOT COMPLETED     7     0  
Adverse Event                 3                 0  
Physician Decision                 2                 0  
Parent/Caregiver Decision                 2                 0  
[1] 6 patients who completed the protocol did not enter optional open-label period.
[2] 2 patients who completed the protocol did not enter the optional open-label period.

Period 2:   Period IV - Optional Open-Label
    Atomoxetine     Placebo  
STARTED     124     0 [1]
COMPLETED     49     0  
NOT COMPLETED     75     0  
Adverse Event                 6                 0  
Lack of Efficacy                 7                 0  
Patient/Caregiver Decision                 46                 0  
Lost to Follow-up                 2                 0  
Protocol Violation                 1                 0  
Withdrawal by Subject                 4                 0  
Physician Decision                 9                 0  
[1] Placebo patients received atomoxetine during the optional open-label 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 atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
Placebo placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
Total Total of all reporting groups

Baseline Measures
    Atomoxetine     Placebo     Total  
Number of Participants  
[units: participants]
  105     32     137  
Age  
[units: years]
Mean ± Standard Deviation
  9.7  ± 2.2     10.0  ± 2.4     9.8  ± 2.3  
Gender  
[units: participants]
     
Female     7     3     10  
Male     98     29     127  
Region of Enrollment  
[units: participants]
     
Italy     105     32     137  
Race/Ethnicity  
[units: participants]
     
Caucasian     104     29     133  
Hispanic     1     3     4  
Height  
[units: centimeters]
Mean ± Standard Deviation
  140.1  ± 15.2     141.6  ± 15.3     140.4  ± 15.1  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  39.3  ± 15.8     41.4  ± 14.1     39.8  ± 15.4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

2.  Secondary:   Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

3.  Secondary:   Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

4.  Secondary:   Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

5.  Secondary:   Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

6.  Secondary:   Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

7.  Secondary:   Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

8.  Secondary:   Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores   [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

9.  Other Pre-specified:   Open-Label Phase Serious Adverse Events   [ Time Frame: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval ]

10.  Other Pre-specified:   Open-Label Phase Nonserious Adverse Events   [ Time Frame: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval ]


  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
Due to the open-ended timing of the open-label period (up to 1.5 years or until commercial availability) the efficacy data from the open-label extension phase is not included except for adverse event data.  


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


No publications provided


Responsible Party: Chielf Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00192023     History of Changes
Other Study ID Numbers: 8856, B4Z-IT-LYCY
Study First Received: September 12, 2005
Results First Received: May 15, 2009
Last Updated: December 9, 2009
Health Authority: Italy: Ministry of Health