NCT01415440

Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD

Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine	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.
DRUG	Placebo	Placebo dosing will parallel that of Lisdexamfetamine.

Timeline

• Start date: 2011-08-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2011-08-12
• Last updated: 2022-08-02
• Results posted: 2019-09-11

Locations

1 site across 1 country: United States