NCT00485550.

Study name	Public title: Comparison of atomoxetine plus either comparator or placebo in children with ADHD who haven't responded to stimulant therapy Scientific title: A randomized, double‐blind comparison of atomoxetine hydrochloride augmented with either extended‐release methylphenidate Hydrochloride (Concerta‐TM) or placebo in children with attention‐deficit/hyperactivity disorder (ADHD) who have not responded to stimulant mono therapy
Methods	Double‐blind, parallel‐group trial Study duration: not reported
Participants	Sample size (actual): 14 Inclusion criteria Patients at least 6 years of age and not more than 12 years of age at visit 1 Patients meet DSM‐IV diagnostic criteria for ADHD Patients retrospectively identified as stimulant non‐responders Patients of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of ≥ 70 on an IQ test) Patients must be able to swallow capsules Exclusion criteria Patients who weigh < 22 kg or > 60 kg at study entry Patients who have a history of bipolar I or bipolar II disorder, psychosis, or pervasive developmental disorder Patients who meet DSM‐IV criteria for anxiety disorder or autism Patients with a history of any seizure disorder and/or rolandic seizures (other than febrile seizures) or prior ECG abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control Patients with a history of severe allergies to > 1 class of medication or multiple adverse drug reactions, including hypersensitivity to MPH
Interventions	Atomoxetin plus placebo Atomoxetin plus MPH
Outcomes	ADHD symptoms Efficacy. Measurement scale and timing of outcome assessment not reported Numbers of serious AEs Safety assessment (unspecified). Measurement scale/method and timing of outcome assessment not reported Non‐serious AEs ECGs. Timing of outcome assessment not reported Clinical laboratory tests (unspecified). Timing of outcome assessment not reported Spontaneous reporting. Timing of outcome assessment not reported
Starting date	January 2004
Contact information	Telephone: 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559 Monday to Friday 9 AM to 5 PM Eastern time (UTC/GMT ‐ 5 h, EST)
Notes	Sponsor: Eli Lilly and Company Declaration of interests: not reported