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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Feasibility and Utility of Autonomic Correlates of Impulsivity in Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD): Extending Translational Research Skills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856063
• Other study ID #: ACTREC JG - 08
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2009
• Last updated: July 5, 2012
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2012
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 48 Months to 70 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis
• Impulsive Behavior

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire)		3-4.5 months	No
Secondary	Children's Global Assessment Scale (C-GAS)		3-4.5 months	No
Secondary	Electrodermal response (EDR)		3-4.5 months	No
Secondary	Response inhibition task		3-4.5 months	No