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Corticosteroid
Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy
Phase 3
Waitlist Available
Led By Floyd R Sallee, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours (at baseline visit)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Summary
The purpose of this study is to find out if children with attention-deficit, hyperactivity disorder (ADHD) have a difference in how their brain cells "fire" or react. The investigators also want to find if brain cell "firing" can tell us how severe of symptoms a child has from ADHD. Finally, the investigators want to see if giving an ADHD medication called atomoxetine can make the ADHD symptoms in a child better and if the improvement shows a change in brain "firing".
Eligible Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognitive Correlates of SICI Change
SICI as a marker of ADHD Behaviors
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: AtomoxetineActive Control1 Intervention
Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children
Group II: PlaceboPlacebo Group1 Intervention
Sugar pill
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
439 Previous Clinical Trials
638,628 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
863 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,931 Previous Clinical Trials
2,744,922 Total Patients Enrolled
96 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
21,050 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Floyd R Sallee, MDPrincipal InvestigatorUniversity of Cincinnati