Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00191945

First received: September 12, 2005

Last updated: January 26, 2010

Last verified: January 2010

History of Changes

Results First Received: February 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Attention Deficit Hyperactivity Disorder
Interventions:	Drug: Atomoxetine Hydrochloride Drug: placebo

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
158 patients enrolled during the Screening Period (Visits 1 and 2), but 7 did not receive study drug and are not included in the 151 patients randomized in the Double-Blind Period.

Reporting Groups

	Description
Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Participant Flow for 2 periods

Period 1: Double-Blind Acute Treatment

	Atomoxetine	Placebo
STARTED	100	51
COMPLETED	94	48
NOT COMPLETED	6	3
Parent's Decision	3	0
Lost to Follow-up	0	1
Non Protocol Compliance	3	0
Physician Decision	0	2

Period 2: Open-Label Treatment Extension

	Atomoxetine	Placebo
STARTED	94	48
COMPLETED	94	48
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Total	Total of all reporting groups

Baseline Measures

	Atomoxetine	Placebo	Total
Number of Participants [units: participants]	100	51	151
Age [units: years] Mean ± Standard Deviation	10.3 ± 2.48	10.3 ± 2.43	10.3 ± 2.46
Gender [units: participants]
Female	21	10	31
Male	79	41	120
Region of Enrollment [units: participants]
Spain	100	51	151
Attention-Deficit/Hyperactivity Disorder Subtype [units: participants]
Inattentive	30	19	49
Hyperactive	5	1	6
Combined (Hyperactive-Inattentive)	64	30	94
Not Assessed	1	1	2
Race/Ethnicity [units: participants]
Caucasian	98	47	145
African	0	1	1
Hispanic	2	3	5
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered ^[1] [units: units on a scale] Mean ± Standard Deviation	39.1 ± 9.0	39.5 ± 9.0	39.2 ± 9.0
Blood Pressure [units: mmHg] Mean ± Standard Deviation
Systolic Blood Pressure	101.2 ± 10.01	100.5 ± 10.01	101.0 ± 9.98
Diastolic Blood Pressure	57.9 ± 7.15	58.0 ± 7.68	57.9 ± 7.31
Body Weight [units: kilograms] Mean ± Standard Deviation	37.9 ± 11.86	37.4 ± 12.18	37.7 ± 11.93

[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. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.

Outcome Measures

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1. Primary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint [ Time Frame: Week 12 ]

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2. Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks [ Time Frame: Week 9 ]

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3. Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks [ Time Frame: Week 6 ]

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4. Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks [ Time Frame: Week 4 ]

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5. Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 [ Time Frame: week 6 and week 12 ]

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6. Secondary:

Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) [ Time Frame: Baseline and 12 weeks ]

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7. Secondary:

Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) [ Time Frame: Baseline and Open-Label Endpoint (107 weeks) ]

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8. Secondary:

Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) [ Time Frame: Baseline and Week 12 ]

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9. Secondary:

Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) [ Time Frame: Baseline to 12 weeks ]

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10. Secondary:

Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) [ Time Frame: Baseline ]

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11. Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension) [ Time Frame: Week 107 ]

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12. Secondary:

Vital Signs - Systolic Blood Pressure [ Time Frame: Baseline and 12 weeks ]

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13. Secondary:

Vital Signs - Diastolic Blood Pressure [ Time Frame: Baseline and 12 weeks ]

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14. Secondary:

Vital Signs - Pulse [ Time Frame: Baseline and 12 weeks ]

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15. Secondary:

Vital Signs - Weight [ Time Frame: Baseline and 12 weeks ]

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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
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Montoya A, Hervas A, Cardo E, Artigas J, Mardomingo MJ, Alda JA, Gastaminza X, García-Polavieja MJ, Gilaberte I, Escobar R. Evaluation of atomoxetine for first-line treatment of newly diagnosed, treatment-naïve children and adolescents with attention deficit/hyperactivity disorder. Curr Med Res Opin. 2009 Nov;25(11):2745-54.

Escobar R, Montoya A, Polavieja P, Cardo E, Artigas J, Hervas A, Fuentes J. Evaluation of patients' and parents' quality of life in a randomized placebo-controlled atomoxetine study in attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Jun;19(3):253-63.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00191945 History of Changes
Other Study ID Numbers:	8836, B4Z-XM-LYDM
Study First Received:	September 12, 2005
Results First Received:	February 6, 2009
Last Updated:	January 26, 2010
Health Authority:	Spain: Ministry of Health

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