Treatment of ADHD With Atomoxetine in Children & Adolescents 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

NCT00607919

B4Z-US-LYEB (Other Identifier)

11672

Details and patient eligibility

About

This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)

Enrollment: 209 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)
• 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 and all related tests

Exclusion criteria

• patients who weigh less than 25 Kg or greater than 70 Kg
• patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
• patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
• females who are pregnant or breastfeeding
• patients with a history of severe allergy to more than one class of medications
• patients with documented history of bipolar I or bipolar II disorder, or psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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209 participants in 2 patient groups, including a placebo group

Atomoxetine

Experimental group

Description:

Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine

Treatment:

Drug: Atomoxetine

Placebo

Placebo Comparator group

Description:

Placebo will be packaged in the same way as experimental drug to enforce double-blind study design. Placebo will be administered orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine.

Treatment:

Drug: Placebo