Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia

Lilly

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder; Dyslexia

Treatments: Drug: Placebo; Drug: Atomoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716274

B4Z-US-LYEI (Other Identifier)

2019-000419-98 (EudraCT Number)

12212

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

110 participants in 2 patient groups, including a placebo group

Atomoxetine

Experimental group

Description:

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). Participants 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. Participants assigned to atomoxetine during the study period II will be re-randomized to either atomoxetine or placebo whereas participants previously assigned to placebo will receive atomoxetine.

Treatment:

Drug: Atomoxetine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo