Back to resultsAutonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
atomoxetine (or placebo)
Sponsored by
About this trial
This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Atomoxetine, Electrodermal Response, Impulsivity, Preschool Children
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire)
Secondary Outcome Measures
Children's Global Assessment Scale (C-GAS)
Electrodermal response (EDR)
Response inhibition task
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00856063
Brief Title
Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Feasibility and Utility of Autonomic Correlates of Impulsivity in Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD): Extending Translational Research Skills
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Atomoxetine, Electrodermal Response, Impulsivity, Preschool Children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atomoxetine (or placebo)
Intervention Description
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 Measure Information:
Title
Hyperactive-Impulsive subscale of SNAP-IV (Swanson, Nolan and Pelham [SNAP] Questionnaire)
Time Frame
3-4.5 months
Secondary Outcome Measure Information:
Title
Children's Global Assessment Scale (C-GAS)
Time Frame
3-4.5 months
Title
Electrodermal response (EDR)
Time Frame
3-4.5 months
Title
Response inhibition task
Time Frame
3-4.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
70 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaswinder Ghuman, M.D.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)
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