Clinical trial NCT00716274: Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Dyslexia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 110
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 participants with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of participants 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 criteria: Inclusion Criteria:

* Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD
* Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia
* Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient
* Child or adolescent participants 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
* Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or dyslexia
* Participants for healthy control group must achieve a score of at least 80 but not \>120 on the Full Scale Intelligence Quotient

Exclusion Criteria:

* Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.
* Participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions
* Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis
* Participants with documented history of autism, Asperger's syndrome, or pervasive developmental disorder
* Females who are pregnant or breastfeeding
* Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks

Primary outcomes:
measure: Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks)
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
Secondary outcomes:
measure: Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category)
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks)
timeFrame: From Week 16, Up to 32 Weeks
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks)
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to 32 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
timeFrame: From Week 16, Up to Week 32
measure: Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
timeFrame: From Week 16, Up to Week 32
measure: The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
timeFrame: 16 Weeks
measure: The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
timeFrame: 16 Weeks
measure: The Number of Participants With TEAE in Participants With Dyslexia
timeFrame: From 16 Weeks Up to Week 32
measure: The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
timeFrame: From Week 16 Up to Week 32
measure: Number of Participants With Adverse Events
timeFrame: 32 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in GORT-4 in Healthy Participants
timeFrame: Baseline, 16 weeks
measure: Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in WMTB-C in Healthy Participants
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants
timeFrame: Baseline, 16 Weeks
measure: Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
timeFrame: Baseline, 32 weeks
measure: Change From Baseline to Endpoint in GORT-4 in Healthy Participants
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in WMTB-C in Healthy Participants
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
timeFrame: Baseline, 32 Weeks
measure: Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants
timeFrame: Baseline, 32 Weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: