Conditions

Attention Deficit Hyperactivity Disorder Dyslexia

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Baseline, 16 weeks

Secondary Outcomes (20)

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
Baseline, 16 weeks
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
Baseline, 16 weeks
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
Baseline, 16 weeks
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
Baseline, 16 weeks
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
Baseline, 16 weeks
+15 more secondary outcomes

Study Arms (2)

Atomoxetine

EXPERIMENTAL

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

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

AtomoxetineDRUG

Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks

Also known as: LY139603

Atomoxetine

PlaceboDRUG

oral, daily, for 16 weeks

Placebo

Eligibility Criteria

Age10 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.