Attention-Deficit/Hyperactivity Disorder (ADHD) Brain Activity Changes to Psychostimulants
A Placebo-controlled Trial of Brain Activity Changes Following Psychostimulant Medication in Adolescent Combined-subtype ADHD
1 other identifier
observational
38
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2004
Longer than P75 for all trials
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedMarch 8, 2011
March 1, 2011
6.1 years
March 7, 2011
March 7, 2011
Conditions
Study Arms (1)
ADHD adolescents and adults
30 adolescents and adults diagnosed with Combined-subtype AD/HD
Eligibility Criteria
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
- Hartford Hospitallead
- Yale Universitycollaborator
Study Sites (1)
Hartford Hospital / The Institute of Living
Hartford, Connecticut, 06106, United States
Biospecimen
Saliva samples for genotyping
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael C. Stevens, Ph.D.
Hartford Hospital
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