Research

The Center of Excellence in ADHD and Related Disorders supports both medical and laboratory studies which represent a critical link between basic and clinical science, often referred to as "translational research.” Translational research is that which can be quickly applied to practical patient treatment. Below is a sampling of studies that we have completed or are still conducting into attention-deficit/hyperactivity disorder (ADHD).

Clinical Trials

Our team of expert clinicians is dedicated to improving clinical care for children, adolescents, and adults with ADHD. Our efforts in pharmacogenomics, functional imaging, and psychiatric care converge in multifaceted clinical trials that transcend the boundaries between basic science and clinical treatment.

Our research explores FDA-approved medications for treatment of ADHD, to understand the way these medications affect brain function, and to predict patients’ response to these drugs. Our overall objective is to determine which treatments are best for which types of individuals. As part of the study, treatment is optimized to maximize response while reducing unwanted effects.

We are currently recruiting for the following clinical trials.

Imaging Stimulant and Nonstimulant Treatments for ADHD: A Network Based Approach

Our recent study of Methylphenidate and Atomoxetine in ADHD: fMRI Measures of Mechanisms and Response produced exciting findings, offering a window into the common and unique neurophysiological mechanisms of response to stimulant and non-stimulant treatments.

We are conducting an in-depth investigation of the impact of the two treatments on relevant neural networks, and evaluating whether improvement is achieved via normalization or other adaptive changes in brain function. As participants in the study, healthy youth and youth with ADHD participate in fMRI brain scanning while performing neuropsychological tasks. Only youth with ADHD are recruited; participants are randomized to receive either atomoxetine or methylphenidate. Youth receiving medication are carefully monitored during weekly visits with our study physicians during the six- to eight-week duration of participation.

Location: Mount Sinai Health System, New York, NY
Sponsor: National Institutes of Health (NIH)
GCO# 11-0161 IRB approved 12-7-2012 to 4-30-2017
Contact: Beth Krone, PhD, or Amanda Kirschenbaum
Tel: 212-241-8012 or 212-241-5269
beth.krone@mssm.edu or amanda.kirschenbaum@mssm.edu

Neurobiological Basis of Response to Vayarin® in Adults with ADHD: an fMRI Study of Brain Activation Pre and Post Treatment

Our prior research suggests that effective non-stimulant treatments for ADHD act through key prefrontal regions that subserve inhibitory and executive functions, although different medications may achieve these effects via distinct mechanisms. The objective of this research is to use functional magnetic resonance imaging (fMRI) with a face go/no-go task to test the prefrontal mechanism of action of the medical food Vayarin. Participants are not treated at the Icahn School of Medicine, but instead are recruited from trials of Vayarin that are enrolling and treating participants at New York University, the Medical Research Network, and the Bioscience Research Center.

Location: Mount Sinai Health System, New York, NY
Sponsor: Enzymotec
GCO# 15-0399 IRB approved 3-24-2015 to 3-23-2017
Contact: Beth Krome, PhD, or Amanda Kirschenbaum
Tel: 212-241-5411 or 212-241-5269
beth.krone@mssm.edu or amanda.kirschenbaum@mssm.edu

Efficacy of Lisdexamfetamine in Adults with ADHD and Sluggish Cognitive Tempo (SCT)

Although Sluggish Cognitive Tempo (SCT) may represent a clinically meaningful condition with distinct underlying pathophysiology that differs from ADHD, research indicates that SCT is common among adults with ADHD. We will investigate treatment response of adults with ADHD and SCT to Vyvanse, a commonly prescribed medication that is FDA approved for treatment of ADHD. Individuals with SCT have been characterized as having the following symptoms:  1) prone to daydreaming instead of concentrating; 2) trouble staying alert/awake in boring situations; 3) being easily confused; 4) being easily bored; 5) feeling spacey/in a fog; 6) frequently feeling lethargic; 7) being underactive/having less energy than others; 8) being slow moving; and 9) not processing information quickly/accurately.

Location: Mount Sinai Health System, New York, NY
Sponsor: Shire
GCO# 14-0564 IRB approved 5-14-2015 to 5-5-2017
Contact: Beth Krone, PhD, or Amanda Kirschenbaum
Tel: 212-241-8012 or 212-241-5269
beth.krone@mssm.edu or Amanda.kirschenbaum@mssm.edu

Ongoing Studies

Medications for ADHD

Although FDA-approved stimulant medications are considered safe for use, the mechanism of action are not fully understood. Our researchers are evaluating non-stimulant alternatives, for children, adolescents, and/or adults, as detailed below.

  • Atomoxetine (Strattera), a norepinepherine reuptake inhibitor that is FDA approved for treatment of ADHD in children, adolescents, and adults.
  • Guanfacine (Intuniv), an alpha2A-adrenergic receptor agonist that was approved by the FDA for treatment of children and adolescents.

Studies in Functional Magnetic Resonance Imaging (fMRI)

We use non-invasive fMRI to take pictures of the brain while you perform simple tasks, which is like playing video games. This allows us to examine the differences in brain activation between individuals with and without ADHD, or before and during treatment with a medication. By examining differences in the processes used in decision-making and impulse control, we gain insight into the mechanisms of ADHD and the ways in which ADHD treatments affect the brain. The ultimate goal is to improve ADHD treatment selection by matching to individual patient characteristics.

There are no known dangers associated with fMRI. To participate, you or your child must be comfortable with small spaces, have no metal in the body that cannot be removed (i.e., metal plates, screws, or braces), and meet inclusion criteria for the study that you choose.

Genetics Studies

In partnership with the Laboratory of Developmental Neuroscience at University of Illinois at Chicago, our researchers study the pharmacogenomics effects of ADHD treatments. We examine the characteristics of DNA donated by parents and children to determine predictors of treatment response and differences in symptom presentation.