Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: New York State Psychiatric Institute

Official Title: 
Examining the Effects of Stimulant Medication on Emotional Lability 
in Patients with Attention Deficit Hyperactivity Disorder (ADHD)   
NCT Number: 
NCT01415440 
Document Date: 
8/19/2019 
 
 

Study Protocol: Youth with and without ADHD were recruited and, after the consent process, 
underwent diagnostic evaluations and multimodal MRI scans. Youth with ADHD were then 
randomized to treatment with either dexamfetamine or placebo in a 1:1 ratio. Double-bind 
conditions were maintained. Treatment continued for 12 weeks with dose optimized to maximize 
symptom improvement with minimal side effects. At the completion of treatment, youth with 
ADHD had a second multimodal MRI scan.  
 
Statistical Analysis Plan: Image processing used the FreeSurfer platform and volumes for the 
amygdala and hippocampus were extracted. Treatment effects on amygdala and hippocampus 
volumes were tested using repeated measures factorial models. Time was a repeated measure 
with two levels (pre- and post-treatment), and Treatment was a between group factor with two 
levels (active and placebo).