An Open-Label, Multicenter, Pilot Study of the Safety and Efficacy of Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)

Eli Lilly and Company1 site in 1 country62 target enrollmentJune 2004

ConditionsAttention Deficit Hyperactivity Disorder

DrugsAtomoxetine Hydrochloride

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 62
Locations: 1
Primary Endpoint: Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

January 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change

Secondary Outcomes

Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine
Assess the safety and tolerability of atomoxetine alone compared with stimulant medications alone and during the time of switch (stimulant plus atomoxetine) as assessed by AEs elicited during open-ended questioning.
Compare atomoxetine and stimulant medications on other secondary measures, including parent preference
Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine
Assess the change in inattentive and hyperactive symptoms among these same patients