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Sponsored by: |
University of Arizona |
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Information provided by: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT00517647 |
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.
Condition | Intervention | Phase |
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Attention Deficit Hyperactivity Disorder |
Drug: Atomoxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Atomoxetine Pilot Study in Preschool Children With ADHD |
Estimated Enrollment: | 40 |
Study Start Date: | April 2004 |
Ages Eligible for Study: | 3 Years to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
University of Arizona Department of Psychiatry | |
Tucson, Arizona, United States, 85724 |
Principal Investigator: | Jaswinder K Ghuman, M.D. | University of Arizona |
Study ID Numbers: | HSC04-22 |
Study First Received: | August 15, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00517647 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ADHD atomoxetine preschool children efficacy safety |
Signs and Symptoms Neurotransmitter Agents Adrenergic Agents Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Atomoxetine Attention Deficit and Disruptive Behavior Disorders Neurologic Manifestations Hyperkinesis Dyskinesias |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Atomoxetine |
Dyskinesias Pharmacologic Actions Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations |