Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 utility in assessing treatment outcome in preschool children with ADHD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.