Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191386
First received: September 12, 2005
Last updated: December 14, 2010
Last verified: December 2010
Results First Received: August 24, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Atomoxetine hydrochloride

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This ongoing study is being conducted as a follow-up investigation of ADHD pediatric patients who completed Study LYBC (NCT00191295).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atomoxetine 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Participant Flow:   Overall Study
    Atomoxetine  
STARTED     228  
6 Months     183  
12 Months     149  
2 Years     105  
3 Years     65  
COMPLETED     68  
NOT COMPLETED     160  
Adverse Event                 16  
Lost to Follow-up                 1  
Entry Criteria Exclusion                 3  
Protocol Violation                 18  
Withdrawal by Subject                 96  
Physician Decision                 11  
Lack of Efficacy                 15  



  Baseline Characteristics
  Hide Baseline Characteristics

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 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Baseline Measures
    Atomoxetine  
Number of Participants  
[units: participants]
  228  
Age  
[units: years]
Mean ± Standard Deviation
  10.69  ± 2.48  
Gender  
[units: participants]
 
Female     33  
Male     195  
Race/Ethnicity, Customized  
[units: Participants]
 
East Asian     228  
Region of Enrollment  
[units: participants]
 
Japan     228  
ADHD Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered/Scored [1]
[units: Units on a scale]
Mean ± Standard Deviation
  22.23  ± 10.42  
Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) [2]
[units: Units on a scale]
Mean ± Standard Deviation
  4.00  ± 1.04  
Mean Age at Onset of Attention Deficit Hyperactivity Disorder (ADHD)  
[units: Years]
Mean ± Standard Deviation
  3.93  ± 1.57  
Age at Onset of ADHD  
[units: Participants]
 
0 Years     1  
1 Years     17  
2 Years     25  
3 Years     49  
4 Years     45  
5 Years     47  
6 Years     40  
7 Years     4  
Duration of ADHD  
[units: Years]
Mean ± Standard Deviation
  6.25  ± 2.85  
Duration of ADHD  
[units: Participants]
 
1 Years     6  
2 Years     8  
3 Years     30  
4 Years     24  
5 Years     32  
6 Years     26  
7 Years     31  
8 Years     21  
9 Years     22  
10 Years     11  
11 Years     4  
12 Years     7  
13 Years     3  
14 Years     3  
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-PL [3]
[units: Participants with Disorder Presently]
 
Oppositional Defiant Disorder     32  
Conduct Disorder     2  
Specific Phobia     3  
Generalized Anxiety Disorder     1  
Obsessive Compulsive Disorder     1  
[1] 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 (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
[2] Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened).
[3] The Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events for Long Term Safety and Tolerability   [ Time Frame: Baseline through 4 years ]

2.  Secondary:   Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score   [ Time Frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years ]

3.  Secondary:   Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)   [ Time Frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years ]

4.  Secondary:   Cytochrome P450 2D6 (CYP2D6) Phenotype Status   [ Time Frame: Over 1 year ]


  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
  Hide More Information

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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191386     History of Changes
Other Study ID Numbers: 9315, B4Z-JE-LYDA
Study First Received: September 12, 2005
Results First Received: August 24, 2010
Last Updated: December 14, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare