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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856063
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
University of Arizona

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 utility in assessing treatment outcome in preschool children with ADHD.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: atomoxetine (or placebo) Phase 4

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: atomoxetine (or placebo)
    Each child will be randomized to receive either ATMX or placebo in the 1st crossover phase followed by the alternative drug condition in the 2nd crossover phase. The study drug (ATMX or placebo) will be administered BID and will be titrated blindly based on clinical response and tolerability. ATMX will be initiated at 0.5 mg/kg/day for 3 days. Based on clinical response, ATMX dose will be titrated to 0.8 mg/kg/day during week 1, 1.4 mg/kg/day during week 2, and a maximum of 1.8 mg/kg/day during week 3, unless serious untoward effects intervene.

Primary Outcome Measures :
  1. Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire) [ Time Frame: 3-4.5 months ]

Secondary Outcome Measures :
  1. Children's Global Assessment Scale (C-GAS) [ Time Frame: 3-4.5 months ]
  2. Electrodermal response (EDR) [ Time Frame: 3-4.5 months ]
  3. Response inhibition task [ Time Frame: 3-4.5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   48 Months to 70 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00856063

Sponsors and Collaborators
University of Arizona
Principal Investigator: Jaswinder Ghuman, M.D. University of Arizona

Responsible Party: University of Arizona Identifier: NCT00856063     History of Changes
Other Study ID Numbers: ACTREC JG - 08
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Keywords provided by University of Arizona:
Attention Deficit Hyperactivity Disorder
Electrodermal Response
Preschool Children

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Impulsive Behavior
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs