Clinical trial NCT01415440
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Vyvanse stimulant medication ADD
Sponsor: New York State Psychiatric Institute
Start date: 2011-08-01; Completion date: 2018-06-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to examine the mechanisms by which stimulant medications reduce symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic Resonance Imaging (MRI), the investigators have found that the volumes of certain brain regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if patients had been treated with stimulant medications, suggesting that stimulants may reduce the symptoms of ADHD by reversing these volume reductions. In a second and related study, the investigators found that in patients with ADHD, emotional processing was normalized when patients were taking stimulant medications. Both studies point to possible mechanisms by which stimulants are effective; however, a significant limitation of these findings is that they were derived from cross-sectional studies.

In this current study, the investigators hope to replicate these treatment effects of stimulants in a prospective, controlled manner. The investigators plan to measure ADHD symptom severity in patients before and after 12-weeks of controlled treatment with either a stimulant medication or placebo while utilizing structural and functional MRI. Combining imaging with a randomized controlled trial will allow us to better assess the effects of stimulants on brain function and structure.

Detailed description:
A cohort of 100 patients with ADHD will be recruited for a 12 week, double-blind, parallel, randomized controlled trial of Lisdexamfetamine (Vyvanse) versus placebo, with 50 patients randomized to Lisdexamfetamine and the other 50 patients to placebo. The investigators will acquire high-resolution, anatomical and functional MRI images at baseline and after 12 weeks of treatment.

In addition, 75 age- and sex-matched healthy control subjects will be imaged at baseline.

Arms: arm 1: 30-70 mg capsule of Lisdexamfetamine once daily for 12 weeks arm 2: 30-70 mg capsule of placebo (sugar pill) once daily for 12 weeks
Interventions: intervention 1: Lisdexamfetamine intervention 2: Placebo
Intervention descriptions: intervention 1: During the first 4 weeks of treatment, the dosage of Lisdexamfetamine will be adjusted based on the patient's response to the medication. The patient will then be maintained at the lowest effective dose for the remaining 8 weeks of treatment. intervention 2: Placebo dosing will parallel that of Lisdexamfetamine.

Protocol documents:
Prot_SAP_000.pdf: 
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).