ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Atomoxetine Pilot Study in Preschool Children With ADHD

This study is currently recruiting participants.
Verified by University of Arizona, July 2007

Sponsored by: University of Arizona
Information provided by: University of Arizona
ClinicalTrials.gov Identifier: NCT00517647
  Purpose

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
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine
Phase IV

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

ChemIDplus related topics:   Atomoxetine    Atomoxetine hydrochloride   

U.S. FDA Resources

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

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child. [ Time Frame: 7 to 13 weeks ]

Secondary Outcome Measures:
  • Decrease in ADHD specific symptom severity and impairment [ Time Frame: 7 to 13 weeks ]

Estimated Enrollment:   40
Study Start Date:   April 2004

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Child must be 36-69 months old at the time of screening to insure that the child can complete the short-term safety and efficacy trial before the age of 6 years.
  • Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months.
  • ADHD symptoms must cause significant functional impairment in the child. Child must meet impairment scale threshold based on Children's Global Assessment Scale (C-GAS, Shaffer, Gould, Brasic et al., 1983) score < 60.
  • Child must have resided with primary caretaker for at least 6 months prior to the screening.
  • Child's heart rate must be within the 98th percentile and blood pressure within the 95th percentile by age and gender and oral temperature values within the normal range.

Exclusion Criteria:

  • Child with prior failed treatment with an adequate trial of ATMX (defined by a minimum of 1.8 mg/kg/day for 4 weeks) or known hypersensitivity to ATMX. Prior failure on stimulants or other psychotropics will not be the sole reason for exclusion.
  • Child is taking MAOI or there have been less than 2 weeks since it was discontinued.
  • Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics). Child should be off of previous psychotropic medications for a minimum duration of one week for stimulants, clonidine or guanfacine; two weeks for bupropion, tricyclic antidepressants, venlafaxine, SSRIs (except fluoxetine and citalopram), valproate; and three weeks for fluoxetine, citalopram, and neuroleptics.
  • Child has narrow angle glaucoma.
  • Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by ATMX (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization).
  • Child with co-morbid psychiatric diagnoses of Major Depression, Bipolar Disorder, a psychotic disorder, or other psychiatric disorders in addition to ADHD that requires concurrent treatment with additional/alternative medication.
  • Current history of physical, sexual, or emotional abuse.
  • The patient has taken an investigational drug within the last 30 days.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517647

Contacts
Contact: Jaswinder K Ghuman, M.D.     520-626-3603     jkghuman@email.arizona.edu    

Locations
United States, Arizona
University of Arizona Department of Psychiatry     Recruiting
      Tucson, Arizona, United States, 85724
      Contact: Jaswinder K Ghuman, M.D.     520-626-3603     jkghuman@email.arizona.edu    
      Principal Investigator: Jaswinder K Ghuman, M.D.            

Sponsors and Collaborators
University of Arizona

Investigators
Principal Investigator:     Jaswinder K Ghuman, M.D.     University of Arizona    
  More Information


Study ID Numbers:   HSC04-22
First Received:   August 15, 2007
Last Updated:   August 15, 2007
ClinicalTrials.gov Identifier:   NCT00517647
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Arizona:
ADHD  
atomoxetine  
preschool children  
efficacy  
safety  

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine
Attention Deficit and Disruptive Behavior Disorders
Neurologic Manifestations
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




Links to all studies - primarily for crawlers