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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00856063
First received: March 3, 2009
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: atomoxetine (or placebo)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire) [ Time Frame: 3-4.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   48 Months to 70 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856063

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

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00856063     History of Changes
Other Study ID Numbers: ACTREC JG - 08
Study First Received: March 3, 2009
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Impulsive Behavior
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014