Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Attention Deficit Hyperactivity Disorder
Drug: atomoxetine (or placebo)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Feasibility and Utility of Autonomic Correlates of Impulsivity in Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD): Extending Translational Research Skills|
- Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire) [ Time Frame: 3-4.5 months ] [ Designated as safety issue: No ]
- Children's Global Assessment Scale (C-GAS) [ Time Frame: 3-4.5 months ] [ Designated as safety issue: No ]
- Electrodermal response (EDR) [ Time Frame: 3-4.5 months ] [ Designated as safety issue: No ]
- Response inhibition task [ Time Frame: 3-4.5 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Drug: atomoxetine (or placebo)
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 of the etiology of ADHD. Although impulsivity is highly heritable, long-term changes in biological systems implicated in impulsive behavior can be effected through intervention as shown by a 61% increase in electrodermal activity 6-8 years later in at-risk preschool children who were randomized to the intervention condition compared with controls randomized to no treatment condition. Early intervention may therefore be essential if dysregulated trajectories in responding within these systems are to be prevented and/or altered.
Atomoxetine (ATMX) blocks the NE transporter (NET), and increases extracellular levels of NE throughout the brain. It is the first nonstimulant drug approved by the FDA for the treatment of ADHD. Recent clinical studies have shown that ATMX significantly reduces symptoms of ADHD as observed by parents and teachers. ATMX has been shown to improve response inhibition in ADHD.
In the proposed research, pre- and post-treatment bio-behavioral and autonomic markers of impulsivity will be assessed in preschool children with ADHD who participate in a double blind, randomized, placebo-controlled crossover treatment with a selective NET inhibitor, atomoxetine, and placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856063
|Principal Investigator:||Jaswinder Ghuman, M.D.||University of Arizona|