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Clinical Trials/NCT01238822
NCT01238822
Completed
Phase 4

Response Variability in Children With ADHD

Children's Hospital Medical Center, Cincinnati1 site in 1 country96 target enrollmentJune 2006

Overview

Phase
Phase 4
Intervention
placebo
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
96
Locations
1
Primary Endpoint
Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
June 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Placebo

Intervention: placebo

Low Dose Methylphenidate

Low dose: 18 mg methylphenidate

Intervention: Methylphenidate

Medium Dose Methylphenidate

Medium Dosage: 36 mg if more than 50 kg and 27 mg if less than 50 kg

Intervention: Methylphenidate

High Dose Methylphenidate

54 mg if more than 50 kg and 36 mg if less than 50 kg

Intervention: Methylphenidate

Outcomes

Primary Outcomes

Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items

Time Frame: end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.

Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54 O - No ADHD symptoms 54 - Highest ADHD symptoms

Study Sites (1)

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