Status:
COMPLETED
Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
University of Arizona
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
48-70 years
Phase:
PHASE4
Brief Summary
The goal of this pilot feasibility and utility study is to develop and validate a method that is reproducible over time for assessing biobehavioral and autonomic markers of impulsivity and their utili...
Detailed Description
Assessing biological markers of ADHD among preschoolers has the potential to elucidate biology-environment interactions, which may have important implications for treatment, and for our understanding ...
Eligibility Criteria
Inclusion
- 48-70 month old children.
- diagnosis of ADHD based on caregiver interview and confirmed by clinical interview.
- level of hyperactivity/impulsivity at home and school (if relevant)
- significant impairment in everyday functioning.
Exclusion
- prior failed treatment with an adequate trial of atomoxetine (ATMX)or known hypersensitivity to ATMX.
- contraindication to ATMX.
- comorbid psychiatric diagnoses of mental retardation,pervasive developmental disorders, bipolar disorder, major depressive disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder, psychotic disorder, or suicidality.
- concurrent treatment with other medications that have central nervous system effects or that affect performance, e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, decongestant or sympathomimetics, sedating antihistamines, or lithium carbonate.
- taking monoamine oxidase inhibitors (MAOI) or less than 2 weeks have passed since MAOI treatment was discontinued.
- medical condition which may interfere with involvement with the study or would be affected negatively by ATMX, including narrow angle glaucoma, significant hepatic or cardiac disease,high heart rate and blood pressure.
- current history of physical, sexual, or emotional abuse.
- has taken an investigational drug within the last 30 days.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00856063
Start Date
March 1 2009
End Date
December 1 2009
Last Update
July 9 2012
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