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

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Atomoxetine  
Total, other (not including serious) adverse events    
# participants affected / at risk     222/228  
Eye disorders    
Conjunctivitis allergic † 1  
# participants affected / at risk     13/228 (5.70%)  
# events     17  
Myopia † 1  
# participants affected / at risk     12/228 (5.26%)  
# events     13  
Gastrointestinal disorders    
Abdominal pain † 1  
# participants affected / at risk     53/228 (23.25%)  
# events     106  
Constipation † 1  
# participants affected / at risk     17/228 (7.46%)  
# events     25  
Dental caries † 1  
# participants affected / at risk     23/228 (10.09%)  
# events     24  
Diarrhoea † 1  
# participants affected / at risk     42/228 (18.42%)  
# events     58  
Nausea † 1  
# participants affected / at risk     28/228 (12.28%)  
# events     47  
Stomatitis † 1  
# participants affected / at risk     20/228 (8.77%)  
# events     27  
Toothache † 1  
# participants affected / at risk     12/228 (5.26%)  
# events     12  
Vomiting † 1  
# participants affected / at risk     29/228 (12.72%)  
# events     45  
General disorders    
Malaise † 1  
# participants affected / at risk     14/228 (6.14%)  
# events     20  
Pyrexia † 1  
# participants affected / at risk     34/228 (14.91%)  
# events     43  
Infections and infestations    
Bronchitis † 1  
# participants affected / at risk     23/228 (10.09%)  
# events     39  
Gastroenteritis † 1  
# participants affected / at risk     36/228 (15.79%)  
# events     53  
Gastroenteritis viral † 1  
# participants affected / at risk     18/228 (7.89%)  
# events     25  
Impetigo † 1  
# participants affected / at risk     15/228 (6.58%)  
# events     17  
Influenza † 1  
# participants affected / at risk     55/228 (24.12%)  
# events     62  
Nasopharyngitis † 1  
# participants affected / at risk     127/228 (55.70%)  
# events     420  
Otitis media † 1  
# participants affected / at risk     12/228 (5.26%)  
# events     14  
Pharyngitis † 1  
# participants affected / at risk     26/228 (11.40%)  
# events     46  
Rhinitis † 1  
# participants affected / at risk     17/228 (7.46%)  
# events     31  
Injury, poisoning and procedural complications    
Arthropod sting † 1  
# participants affected / at risk     18/228 (7.89%)  
# events     41  
Contusion † 1  
# participants affected / at risk     30/228 (13.16%)  
# events     51  
Excoriation † 1  
# participants affected / at risk     17/228 (7.46%)  
# events     30  
Fall † 1  
# participants affected / at risk     18/228 (7.89%)  
# events     26  
Joint sprain † 1  
# participants affected / at risk     22/228 (9.65%)  
# events     30  
Metabolism and nutrition disorders    
Decreased appetite † 1  
# participants affected / at risk     30/228 (13.16%)  
# events     36  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Skin papilloma † 1  
# participants affected / at risk     13/228 (5.70%)  
# events     17  
Nervous system disorders    
Headache † 1  
# participants affected / at risk     67/228 (29.39%)  
# events     173  
Somnolence † 1  
# participants affected / at risk     34/228 (14.91%)  
# events     37  
Respiratory, thoracic and mediastinal disorders    
Cough † 1  
# participants affected / at risk     22/228 (9.65%)  
# events     27  
Epistaxis † 1  
# participants affected / at risk     22/228 (9.65%)  
# events     55  
Oropharyngeal pain † 1  
# participants affected / at risk     12/228 (5.26%)  
# events     14  
Rhinitis allergic † 1  
# participants affected / at risk     22/228 (9.65%)  
# events     30  
Upper respiratory tract inflammation † 1  
# participants affected / at risk     49/228 (21.49%)  
# events     139  
Skin and subcutaneous tissue disorders    
Eczema † 1  
# participants affected / at risk     21/228 (9.21%)  
# events     29  
Urticaria † 1  
# participants affected / at risk     12/228 (5.26%)  
# events     24  
Surgical and medical procedures    
Tooth extraction † 1  
# participants affected / at risk     14/228 (6.14%)  
# events     22  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0



  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: 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