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

NCT00856063 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-07-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Jaswinder Ghuman, M.D. · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
48 Months
Max Age
70 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856063 on ClinicalTrials.gov