Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine Hydrochloride

Drug: Placebo

Drug: Methylphenidate Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485550

B4Z-MC-LYBU

7065

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.

Enrollment

14 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients will be at least 6 years of age and not more than 12 years of age at visit 1
Patients must meet DSM-IV diagnostic criteria for ADHD
Patients must be retrospectively identified as stimulant non-responders
Patients must be 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 greater than or equal to 70 on an IQ test)
Patients must be able to swallow capsules

Exclusion criteria

Patients who weigh less than 22 kg or more than 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 electroencephalogram (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 more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH