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 multi-faceted clinical trials that transcend the boundaries between basic science and clinical treatment.

Our current drug trials explore FDA approved medications for treatment of ADHD to predict patients’ response to these drugs in the hope of determining optimal treatment conditions while reducing or eliminating negative effects.

Medications for ADHD

Traditionally, ADHD has been treated with stimulant medications; however, non-stimulant medications have been developed to provide alternatives for individuals who are not candidates for traditional treatments. Although considered safe for use, the mechanism of action for these FDA approved medications is not well-understood. Our researchers are providing this information for:

Atomoxetine (Strattera), a norepinepherine re-uptake 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.

Neurobiological Basis of Response to Guanfacine XR in Children and Adolescents with ADHD: An fMRI Study of Activation Pre- and Post- Treatment

This research treatment study looks at neurobiological response to INTUNIV XR (extended release Guanfacine Hydrochloride), a non-stimulant medication with FDA approval for treatment of ADHD. Participants receive a psychiatric and physical examination with labs. Those who are diagnosed with ADHD receive an fMRI brain scan while performing neuropsychological tasks, prior to randomization to a placebo or medication group. These scans are conducted without contrast or sedation. This is a exible dose titration study, so all children start on the lowest dose of Intuniv (or placebo). Childrens progress is carefully monitored during weekly visits with our study physicians during the 4 to 6 week titration and 2 week maintenance phase (total of 6-8 weeks). While still on the maintenance dose, the child receives a second fMRI scan and an abbreviated psychiatric and physical examination. To ensure that children in the placebo group have opportunity to receive treatment under our doctors supervision and to provide stabilization for children in the medication group, all children may continue to  see our doctors for an additional 2 months after their participation in the study has ended. During this time, the doctors may provide a prescription an FDA approved medication other than INTUNIV, depending on their best clinical judgment and the childs responses to treatment during the study.

GCO# 09-1825 IRB approved 11-3-2012 to 11-2-2014

Contact: 
Beth Krone, PhD
Tel: 212-241-8012
E-mail: beth.krone@mssm.edu

Imaging Stimulant and Non-Stimulant Treatments for ADHD: A Network Based Approach

Our recent work on the study 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. To enhance the interpretation and clinical utility of these results, 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: Imaging Stimulant and Non-Stimulant Treatments for ADHD: A Network Based Approach, healthy youth and youth with ADHD will participate in fMRI brain scanning while performing neuropsychological tasks. Only youth with ADHD will be randomized to one of the medication treatment groups. Youth receiving medication will be carefully monitored during weekly visits with our study physicians during the 6-8 week duration of participation.

Location: Mount Sinai Health System, New York, NY
Sponsor: NIH

GCO# 11-0161 IRB approved 12-7-2012 to 4-30-2014

Contact:
Beth Krone, PhD or Anne Claude Bedard, PhD
Tel: 212-241-8012
E-mail: beth.krone@mssm.edu or ac.bedard@mssm.edu

Neurobiological Basis of Response to Vyvanse in Adults with ADHD: An fMRI Study of Brain Activation Pre- and Post- Treatment

Dr. Jeffrey Newcorn and his team at the Clinical Trials Program are evaluating brain activation in response to Vyvanse, a medication used in the treatment of Adults with Attention Deficit Hyperactivity Disorder (ADHD).
Please call if you are between 18-55 years of age and experiences symptoms of ADHD, like being easily distracted, making careless mistakes, being forgetful in daily activities, having difficulty paying attention, and difficulty organizing.

The study involves no cost: a comprehensive psychiatric and physical screening to determine whether you have ADHD; pre-and post-treatment fMRI scanning; weekly visits with our physicians; about two months of medication; referral for on-going care with progress report of participation.

A small stipend is provided.

Location: Mount Sinai Health System, New York, NY
Sponsor: Shire Pharmaceuticals Inc.

GCO# 09-1186 IRB approved to 3-24-2014

Contact:
Beth Krone, PhD or Stephanie Duhoux, PhD
Tel: 212-241-7009
E-mail: beth.krone@mssm.edu or stephanie.duhoux@mssm.edu

A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared with OROS-MPH (CONCERTA®) with a Placebo Reference Arm, in Adolescents Aged 13-17 Years with Attention-deficit/Hyperactivity Disorder (ADHD)

BRANY IRB 12-10-190

Contact:
Beth Krone, PhD or Stephanie Duhoux, PhD
Tel: 212-241-8012 or 212-241-7009
E-mail: beth.krone@mssm.edu or stephanie.duhoux@mssm.edu

A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared with OROS-MPH (CONCERTA®) with a Placebo Reference Arm, in Adolescents Aged 13-17 Years with Attention-deficit/Hyperactivity Disorder (ADHD)

BRANY IRB 12-10-189

Contact:
Beth Krone, PhD or Stephanie Duhoux, PhD
Tel: 212-241-8012 or 212-241-7009
E-mail: beth.krone@mssm.edu or stephanie.duhoux@mssm.edu


Contact Us

For more information about participation in research
Tel.: 212-241-8012
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For more information about ADHD Center Clinical Programs
Tel.: 212-241-5420
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For more information about Learning Disorders
Tel.: 212-241-4423
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Center of Excellence for ADHD and Related Disorders
Icahn School of Medicine
Department of Psychiatry
One Gustave L. Levy Place
Box 1230
New York, NY 10029