An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00192023

First received: September 12, 2005

Last updated: December 9, 2009

Last verified: December 2009

History of Changes

Results First Received: May 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder
Interventions:	Drug: atomoxetine 0.5 mg/kg/day Drug: placebo Drug: atomoxetine 1.2 mg/kg/day Drug: atomoxetine 1.2-1.4 mg/kg/day

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 Period I=Screening. Study Period II=Standardized behavioral management program for parents (156 entered, 17 discontinued). Study Period III=Double-Blind (randomization). Two patients did not have post-baseline values for the primary endpoint and were not included in Baseline or efficacy analyses. Study Period IV=Optional open-label phase.

Reporting Groups

	Description
Atomoxetine	atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
Placebo	placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.

Participant Flow for 2 periods

Period 1: Period III - Double-Blind

	Atomoxetine	Placebo
STARTED	107	32
COMPLETED	100 ^[1]	32 ^[2]
NOT COMPLETED	7	0
Adverse Event	3	0
Physician Decision	2	0
Parent/Caregiver Decision	2	0

[1]	6 patients who completed the protocol did not enter optional open-label period.
[2]	2 patients who completed the protocol did not enter the optional open-label period.

Period 2: Period IV - Optional Open-Label

	Atomoxetine	Placebo
STARTED	124	0 ^[1]
COMPLETED	49	0
NOT COMPLETED	75	0
Adverse Event	6	0
Lack of Efficacy	7	0
Patient/Caregiver Decision	46	0
Lost to Follow-up	2	0
Protocol Violation	1	0
Withdrawal by Subject	4	0
Physician Decision	9	0

[1]	Placebo patients received atomoxetine during the optional open-label period.

Baseline Characteristics

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Reporting Groups

	Description
Atomoxetine	atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
Placebo	placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
Total	Total of all reporting groups

Baseline Measures

	Atomoxetine	Placebo	Total
Number of Participants [units: participants]	105	32	137
Age [units: years] Mean ± Standard Deviation	9.7 ± 2.2	10.0 ± 2.4	9.8 ± 2.3
Gender [units: participants]
Female	7	3	10
Male	98	29	127
Region of Enrollment [units: participants]
Italy	105	32	137
Race/Ethnicity [units: participants]
Caucasian	104	29	133
Hispanic	1	3	4
Height [units: centimeters] Mean ± Standard Deviation	140.1 ± 15.2	141.6 ± 15.3	140.4 ± 15.1
Weight [units: kilograms] Mean ± Standard Deviation	39.3 ± 15.8	41.4 ± 14.1	39.8 ± 15.4

Outcome Measures

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1. Primary:

Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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3. Secondary:

Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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4. Secondary:

Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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5. Secondary:

Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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6. Secondary:

Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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7. Secondary:

Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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8. Secondary:

Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores [ Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks) ]

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9. Other Pre-specified:

Open-Label Phase Serious Adverse Events [ Time Frame: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval ]

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10. Other Pre-specified:

Open-Label Phase Nonserious Adverse Events [ Time Frame: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval ]

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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
Due to the open-ended timing of the open-label period (up to 1.5 years or until commercial availability) the efficacy data from the open-label extension phase is not included except for adverse event data.

Results Point of Contact:

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

No publications provided

Responsible Party:	Chielf Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00192023 History of Changes
Other Study ID Numbers:	8856, B4Z-IT-LYCY
Study First Received:	September 12, 2005
Results First Received:	May 15, 2009
Last Updated:	December 9, 2009
Health Authority:	Italy: Ministry of Health

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