Effects of Atomoxetine on Brain Activation During Attention and Reading Tasks in Patients With ADHD & Comorbid Dyslexia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00716274

Purpose

This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in patients ages 10 to 16 years old with ADHD and comorbid dyslexia

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder Dyslexia	Drug: Atomoxetine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Neurophysiology of Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Dyslexia: Functional Magnetic Resonance Imaging (fMRI) Measures of Brain Activation During Attention and Reading Tasks Pre- and Post-Atomoxetine Treatment

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder MRI Scans

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess the effect of atomoxetine on brain activation pattern during attention & reading tasks in children & adolescents with ADHD & comorbid dyslexia and ADHD alone. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the correlation between the patterns of brain activation, measured via fMRI, & the clinical findings (ADHDRS & reading scores) in the ADHD alone group & in ADHD with comorbid dyslexia group. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To assess the effect of atomoxetine on brain activation patterns as patients perform the Stroop attention task, pseudoword rhyming, and semantic-category tasks during fMRI in patients with ADHD alone compared to patients with ADHD & comorbid dyslexia. [ Time Frame: 16 ] [ Designated as safety issue: No ]
To assess brain activation patterns during fMRI as patients perform the Stroop attention task, pseudoword rhyming, & semantic-category tasks in patients with ADHD alone compared with healthy control subjects. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To assess brain activation patterns during fMRI as patients perform the Stroop attention task, pseudoword rhyming, & semantic-category tasks in patients with ADHD & comorbid dyslexia compared with healthy control subjects. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To assess Basic Reading, fluency, comprehension, & spelling skills as measured by Woodcock Johnson III in patients with ADHD alone & ADHD plus comorbid dyslexia. [ Time Frame: 16 weeks, atomoxetine versus placebo; 32 weeks atomoxetine ] [ Designated as safety issue: No ]
To assess phonological processing as measured by the Comprehensive Test of Phonological Processing in patients with ADHD alone & ADHD plus comorbid dyslexia. [ Time Frame: 16 weeks, atomoxetine versus placebo; 32 weeks atomoxetine ] [ Designated as safety issue: No ]
To assess oral reading rate, accuracy, fluency, and comprehension, and overall reading performance as measured by the Gray Oral Reading Tests-4 & Test of Word Reading Efficiency in patients with ADHD alone & ADHD plus comorbid dyslexia. [ Time Frame: 16 weeks, atomoxetine versus placebo; 32 weeks atomoxetine ] [ Designated as safety issue: No ]
To assess working memory & executive functioning as measured by WMTB-C & Brown Attention-Deficit Disorder Scale-Adolescent Version (BADD-A), respectively in patients with ADHD alone & ADHD plus comorbid dyslexia. [ Time Frame: 16 weeks, atomoxetine versus placebo; 32 weeks atomoxetine ] [ Designated as safety issue: No ]
To evaluate maintenance of benefit after discontinuation of treatment with atomoxetine in patients who were previously assigned to atomoxetine during the acute treatment period. These patients will be re-randomized to atomoxetine or placebo. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To assess safety & tolerability of atomoxetine in the ADHD alone group, ADHD with comorbid dyslexia group, & dyslexia alone group as assessed by laboratory, vitals, ECG measures, & adverse events collection. [ Time Frame: 16 & 32 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	September 2008
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Atomoxetine will be administered at 1.0 to 1.4 mg/Kg/day given orally once daily in the morning for 16 weeks (study period II). Patients who complete the study period II will be re-randomized in the study period III of 16-week duration to assess maintenance of benefit following discontinuation of treatment with atomoxetine. Patients assigned to atomoxetine during the study period II will be re-randomized to either atomoxetine or placebo whereas patients previously assigned to placebo will receive atomoxetine.	Drug: Atomoxetine Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 32 weeks Other Name: LY139603
Placebo Comparator: 2 Placebo will be packaged in the same way as active comparator will to enforce double-blind study design	Drug: Placebo oral, daily, for 32 weeks

Arms

Assigned Interventions

Experimental: 1

Atomoxetine will be administered at 1.0 to 1.4 mg/Kg/day given orally once daily in the morning for 16 weeks (study period II). Patients who complete the study period II will be re-randomized in the study period III of 16-week duration to assess maintenance of benefit following discontinuation of treatment with atomoxetine. Patients assigned to atomoxetine during the study period II will be re-randomized to either atomoxetine or placebo whereas patients previously assigned to placebo will receive atomoxetine.

Drug: Atomoxetine

Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 32 weeks

Other Name: LY139603

Placebo Comparator: 2

Placebo will be packaged in the same way as active comparator will to enforce double-blind study design

Drug: Placebo

oral, daily, for 32 weeks

Detailed Description:

This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of ADHD in patients with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of patients with ADHD only and dyslexia only to determine to what extent symptomatic change in the comorbid ADHD & dyslexia is achieved independently by atomoxetine effects on either condition. A healthy control group of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects & effects of treatment that may be interpreted as normal maturation. The healthy control group will not be treated with any study medications.

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must meet DSM-IV-TR criteria for ADHD
Patient must meet DSM-IV-TR criteria for dyslexia
Patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
Child or adolescent patients must be 10 to 16 years old
Must be able to communicate in English
Must be able to swallow capsules
Be reliable to keep appointments for clinic visits & all related tests
Subjects for healthy control group do not meet DSM-IV-TR criteria for AHHD and/or dyslexia
Subjects for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient

Exclusion Criteria:

Patients who weigh less than 25 kg or greater than 70 kg
Patients with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions
Patients with prior diagnosis of bipolar I or bipolar II disorder or psychosis
Patients with documented history of autism, Asperger's syndrome, or pervasive developmental disorder
Females who are pregnant or breastfeeding
Patients treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716274

Contacts

Contact: There is only one site for this clinical trial 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

United States, Connecticut
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.	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Eli Lilly

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

Additional Information:

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

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00716274 History of Changes
Other Study ID Numbers:	12212, B4Z-US-LYEI
Study First Received:	July 14, 2008
Last Updated:	March 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Dyslexia
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Language Disorders

Communication Disorders
Neurobehavioral Manifestations
Learning Disorders
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012