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

History of Changes

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
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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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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.

[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 ]

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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 ]

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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 ]

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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 ]

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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 ]

Show Outcome Measure 5

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 ]

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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 ]

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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 ]

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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 ]

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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:	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

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