Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD

Lilly

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485875

B4Z-MC-LYCI

7953

Details and patient eligibility

About

The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.

Enrollment

62 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must be at least 6 years of age and not yet be 18 years of age at the completion of visit 6
Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
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 a IQ test)
Patients must be able to swallow capsules

Exclusion criteria

Patients who weigh less than 22 kg or more than 70 kg at study entry
Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder
Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, 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
Patients who have glaucoma