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Evaluation of Continuous Symptom Treatment of ADHD | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT00486122

Evaluation of Continuous Symptom Treatment of ADHD

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...

Lead sponsor: Eli Lilly and Company•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Eli Lilly and Company

Age

6 - 12 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 13, 2007Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment282

Start dateSep 2003

Last updatedJun 13, 2007

Condition

Attention Deficit Hyperactivity Disorder

Locations shown

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Columbus, Ohio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2007Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions