NCT01310439

Brief Summary

The purpose of this study is to examine the neural basis of response inhibition, working memory, and sustained attention in adolescents and adults with Attention-Deficit/Hyperactivity Disorder (ADHD), with particular emphasis on quantifying the effects of methylphenidate (i.e., treatment with psychostimulants) on neural function. Participants will undergo electrophysiological measurement of brain function during laboratory cognitive tasks. This research is aimed to develop a better understanding of how ADHD neural dysfunction relates to clinical presentation and medication response during the transition from adolescence to adulthood. The specific aims and hypotheses are: Specific Aim: To characterize the effect of Ritalin (methylphenidate) on neural activity underlying performance on the response inhibition task in ADHD adolescents and adults. Hypothesis 1) Methylphendiate will increase N2 and P3 amplitude in ADHD persons during medicated EEG sessions; Hypothesis 2) There will be a significant age × medication interaction such that ADHD teens will show increased amplitude of N2 while medicated, particularly at frontal sites, whereas ADHD adults will show differentially greater effect of medication on P3 amplitude and latency at central sites. Hypothesis 3) Brain activity assessed by fMRI will differ between unmedicated and medicated states.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

6.1 years

First QC Date

March 7, 2011

Last Update Submit

March 7, 2011

Conditions

Study Arms (1)

ADHD adolescents and adults

30 adolescents and adults diagnosed with Combined-subtype AD/HD

Eligibility Criteria

Age13 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from the community and referred from psychiatric outpatient clinics.

You may qualify if:

  • ADHD will be diagnosed based on DSM-IV criteria for ADHD combined subtype ADHD. Combined subtype ADHD requires at least 6 of 9 possible symptoms within both the Hyperactive-Impulsive symptom cluster and the Inattentive symptom cluster. This will be assessed using information gathered from the K-SADS-PL interview with either the potential participant or their parent, and from published self- and parent-report ADHD symptom rating scales (Brown, 1996; Barkley, 1998). Predominantly Inattentive ADHD persons will not be included. The Predominantly Inattentive subtype is the subject of much theoretical debate, as it is not clear that these persons represent a unitary disorder, or that they are neurobiologically similar to combined-subtype ADHD (Millich et al., 2001).

You may not qualify if:

  • Only ADHD persons who are regularly prescribed a classic psychostimulant(Ritalin, dexedrine, etc) will be recruited. This will confirm that such persons show a beneficial therapeutic response to stimulants that can be characterized using brain function measurements. While this will prevent the comparison of brain activity response among various medications, it will simplify interpretation of the results. Finally, subjects will be excluded if they are taking any adjunctive medication for ADHD symptoms (e.g., Wellbutrin, etc.) or another psychoactive medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital / The Institute of Living

Hartford, Connecticut, 06106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples for genotyping

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michael C. Stevens, Ph.D.

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

May 1, 2004

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations