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
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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

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 ]

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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 ]

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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 ]

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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
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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

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