Evaluation of Continuous Symptom Treatment of ADHD

Lilly

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine Hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00486122

B4Z-US-LYCC

7972

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.

Enrollment

282 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised
Males or females who are at least 6 years old and no more than 12 years old prior to visit 2
Patients must be able to swallow capsules
Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 70 or more if formal IQ testing were administered.
Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)

Exclusion criteria

Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1)
Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis
Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder.
Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient
Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.