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Atomoxetine Pilot Study in Preschool Children With ADHD

NCT00517647 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-07-09

No results posted yet for this study

Summary

The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has given permission to study this drug in this age group.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

ATMX

Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Jaswinder K Ghuman, M.D. · University of Arizona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00517647 on ClinicalTrials.gov