Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera

Eli Lilly and Company1 site in 1 country282 target enrollmentSeptember 2003

ConditionsAttention Deficit Hyperactivity Disorder

DrugsAtomoxetine Hydrochloride Placebo

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 282
Locations: 1
Primary Endpoint: 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
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 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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

June 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy compared with placebo in children with ADHD
Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the evenings compared with placebo in children with ADHD
Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD based on the CGIP-M
To assess the effect of dosing atomoxetine in the morning versus placebo on measures of executive functioning
Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy compared with placebo for measures of adaptive functioning in children with ADHD
Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy in the evenings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
To examine the onset of action during the first week of treatment in the morning versus in the evening versus placebo
To assess the effect of dosing atomoxetine in the evening versus placebo on measures of executive functioning
To compare morning versus evening dosing versus placebo as assessed by the CGI-ADHD-S
To assess the safety and tolerability of atomoxetine dosed in the morning versus in the evening versus placebo