NCT01330693

Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy

Cortical Excitability: Phenotype and Biomarker in ADHD Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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".

Detailed description

This study will evaluate Short Interval Intracortical Inhibition (SICI) measured by pTMS as a marker of the hyperactive-impulsive dimension in 120 ADHD 7-12 years, medication-free children. This study will characterize the effects of a single dose of atomoxetine compared to placebo on cognitive correlates of SICI change. Participants will be randomized 2:1 to either atomoxetine or placebo. The study will also characterize the effects of four weeks of atomoxetine treatment on cortical inhibition and will correlate SICI change with clinical outcomes.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	Atomoxetine	Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children. Single dose of 0.5 mg/kg at baseline visit. Then dose adjusted in an open-label design afterwards.
DRUG	Sugar Pill	In-active sugar pill randomly assigned at baseline visit

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-04-07
• Last updated: 2015-08-19

Locations

2 sites across 1 country: United States