Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: atomoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191880

7649

B4Z-CA-LYCS

Details and patient eligibility

About

Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder

Sex: All

Ages: 8 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12.

Exclusion criteria

-Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)