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

NCT00856063 | Completed Phase 4

• 1 other identifier: ACTREC JG - 08
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Atomoxetine; Electrodermal Response; Impulsivity; Preschool Children

Outcome Measures

Primary Outcomes (1)

• Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire)

  3-4.5 months

Secondary Outcomes (3)

• Children's Global Assessment Scale (C-GAS)

  3-4.5 months

• Electrodermal response (EDR)

  3-4.5 months

• Response inhibition task

  3-4.5 months

Interventions

atomoxetine (or placebo) DRUG

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.

Eligibility Criteria

• Age: 48 Months - 70 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Impulsive Behavior

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Jaswinder Ghuman, M.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 5, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 9, 2012

Record last verified: 2012-07