Comparison of Atomoxetine and Placebo in Children With ADHD and/or Reading Disorder - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191906

Purpose

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type ADHD, patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder Reading Disorder	Drug: Atomoxetine Hydrochloride Drug: placebo	Phase IV

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, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In subset of patients 10 years or older, compare performance on SSRT and a phonological task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Compare performance between groups on SSRT and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Working memory by Corsi Block Tapping Test (CBTT) [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
Adverse Events (AEs) [ Time Frame: over 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	76
Study Start Date:	April 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Atomoxetine, 1.2 mg/kg/day, PO for 4 weeks, 2 week washout period and cross-over to placebo, QD, PO for 4 weeks	Drug: Atomoxetine Hydrochloride Drug: placebo
B: Experimental Placebo, QD, PO for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks	Drug: Atomoxetine Hydrochloride Drug: placebo

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder

Exclusion Criteria:

Patients with Conduct Disorder
Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191906

Locations

Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gent, Belgium, 9000
Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amsterdam, Netherlands, 1081 BT
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Almere, Netherlands, 1311 RL
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Breda, Netherlands, 4819 EV
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vught, Netherlands, 5260 GB

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 9AM - 5PM 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:	7955, B4Z-MC-LYCK
Study First Received:	September 12, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00191906
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Atomoxetine
Dyslexia
Attention Deficit and Disruptive Behavior Disorders
Language Disorders
Learning Disorders
Dyskinesias
Signs and Symptoms

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Neurobehavioral Manifestations
Communication Disorders

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