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

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

ChemIDplus related topics:

Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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:

After 4 weeks of therapy, improvement in speed of inhibition as shown by a statistically significant shorter Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm.

Secondary Outcome Measures:

After 4 weeks of therapy, in subset of patients 10 years or older, compare performance on SSRT and a phonological task.
After 4 weeks of therapy, compare performance between groups on SSRT and lexical decision task.
After 4 weeks of therapy, compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task.
After 4 weeks of therapy, compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls.

Estimated Enrollment:	80
Study Start Date:	April 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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

Study ID Numbers:	7955, B4Z-MC-LYCK
First Received:	September 12, 2005
Last Updated:	January 9, 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 September 05, 2008

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