A Study Comparing the Effect of Atomoxetine vs Other Standard Care Therapy on the Long Term Functioning in ADHD Children and Adolescents - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00447278

Purpose

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of ADHD) on the long term functioning in approximately 400 children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Patients will be pharmacological naïve prior to entry into the study.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine Drug: Other standard therapy for ADHD	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), mean change in achievement domain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CHIP-CE PRF, mean change in achievement domain [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]
Change in the CHIP-CE PRF total score and domains (satisfaction, comfort, resilience and risk avoidance) [ Time Frame: 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) [ Time Frame: 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Attention-Deficit/Hyperactivity Disorder rating scale - parent Version: investigator adminitered and scored(ADHD-RS-IV Parent:Inv) [ Time Frame: 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Clinical Global Impression attention -Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S) [ Time Frame: 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Change in the CHIP-CE CRF for children (6-11 years) and CHIP-AE for adolescents (>11-17 years) [ Time Frame: 4 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Correlation between CHIP-CE Parent rated with CHIP-CE child rated and CHIP AE adolescent rated [ Time Frame: 4 months, 6 months ] [ Designated as safety issue: No ]
Treatment-emergent adverse events [ Time Frame: 4 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	399
Study Start Date:	March 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Atomoxetine 0.5 mg/kg/day QD or BID for 1 week then 1.2-1.8 mg/kg/day QDor BID for 6 months, up to an additional 6 months optional extension
B: Active Comparator	Drug: Other standard therapy for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inclusion criteria:
- 6 to 16 years old
- Diagnosis of ADHD according DSM IV confirmed by Kiddie SADS PL
- Pharmacological naïve
- Normal intelligence as assessed by investigator
- Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion Criteria:

Exclusion criteria
- History of bipolar disorder, any history of psychosis or autism spectrum disorder
- History of any seizure disorder
- Significant prior or current medical conditions
- History of alcohol or drug abuse within the past 3 months
- Patients who are taking concurrently any of the excluded medications in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447278

Show 35 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11576, B4Z-EW-LYDY
Study First Received:	March 12, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00447278
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009