Overview

Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Atomoxetine Hydrochloride
Criteria
Inclusion Criteria:

- Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as
severity criteria

- Subjects must be aged 6 to 16 years

- Subjects must not have taken any medication used to treat ADHD or they must have
completed the washout procedures

- Subjects must be able to swallow capsules

- Subjects 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 80 or more if formal IQ testing were
administered.

Exclusion Criteria:

- Weigh less than 20 kg or more than 60 kg at study entry

- Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental
disorder

- Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator

- Have a history of any seizure disorder (other than febrile seizures) or prior ECG
abnormalities related to epilepsy, or subjects who have taken (or are currently
taking) anticonvulsants for seizure control

- Subjects who have a history of severe allergies to more than 1 class of medications or
multiple adverse drug reactions.