Clinical trial

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

Name

12212

Description

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

Trial arms

Trial start

2008-09-01

Estimated PCD

2016-07-01

Trial end

2016-07-01

Status

Completed

Phase

Early phase I

Treatment

Atomoxetine

Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks

Arms:

Atomoxetine

Other names:

LY139603

Placebo

oral, daily, for 16 weeks

Arms:

Placebo

Size

110

Primary endpoint

Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)

Baseline, 16 Weeks

Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)

Baseline, 16 Weeks

Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)

Baseline, 16 Weeks

Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks)

Baseline, 16 Weeks

Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia

Baseline, 16 weeks

Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone

Baseline, 16 Weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}

Updated at

2022-11-04

1 organization

2 products

2 indications

Product

Placebo

Indication

ADHD

Indication

Dyslexia

Organization

Eli Lilly and Company

Product

Atomoxetine