Response Variability in Children With Attention Deficit Hyperactivity Disorder (ADHD)

NCT01238822 | Completed Phase 4 Results

• 1 other identifier: R01MH074770
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

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

  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

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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Low Dose Methylphenidate

ACTIVE COMPARATOR

Low dose: 18 mg methylphenidate

Drug: Methylphenidate

Medium Dose Methylphenidate

ACTIVE COMPARATOR

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

Drug: Methylphenidate

High Dose Methylphenidate

ACTIVE COMPARATOR

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

Drug: Methylphenidate

Interventions

Methylphenidate DRUG

18 mg methylphenidate

Also known as: Concerta

Low Dose Methylphenidate

placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Consent: The family must provide signature of informed consent by parents or legal guardians.
• Age at time of Screening: 7 years to 11 years, inclusive
• Gender: includes male and female children.
• ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD, Inattentive or Combined subtype. Normal controls must not meet DSM-IV criteria for ADHD, any subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
• Cognitive Functioning: IQ of greater than 80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
• Learning Disability: All children will be administered the abbreviated WIAT including the Spelling, Reading, and Math subtests. Children must score above 80 on all three WIAT subtests.
• School: Children must be enrolled in a school setting from which teacher ratings can be obtained.

You may not qualify if:

• Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
• History of Psychiatric Medications: Children who have a history of taking any medication for psychological or psychiatric problems will be excluded from participation.
• Developmental Disabilities. As a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
• Organic Brain Injury: Children must not have a history of head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Froehlich TE, Epstein JN, Nick TG, Melguizo Castro MS, Stein MA, Brinkman WB, Graham AJ, Langberg JM, Kahn RS. Pharmacogenetic predictors of methylphenidate dose-response in attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1129-1139.e2. doi: 10.1016/j.jaac.2011.08.002. Epub 2011 Sep 15.

  PMID: 22024001 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jeff Epstein
• Organization: Cincinnati Children's Hospital Medical Center

jeff.epstein@cchmc.org

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 11, 2010
• Study Start: June 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 4, 2012
• Results First Posted: April 4, 2012

Record last verified: 2012-04

Locations

US (1)