Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation



Status:Completed
Conditions:Psychiatric, ADHD
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 55
Updated:6/8/2018
Start Date:March 2013
End Date:December 2013

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The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication
used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity
in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for
participation in this study because they have ADHD and are willing to participate in two
Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their
symptoms. Another purpose of this study is to collect and bank samples of blood for research
to examine how genes influence brain activation seen during the brain scans. The study also
seeks to find out whether certain genes are related to ADHD. Participants' entire genetic
makeup will not be determined from this sample.


Inclusion Criteria:

- Primary DSM-IV-TR diagnosis of adult ADHD (inattentive, hyperactive-impulsive or
combined subtype), established via the ACDS v1.2.

- Must be between 18-55 years, inclusive.

- Provides written informed consent.

Exclusion Criteria:

- Lifetime or current diagnosis of bipolar disorder, schizophrenia or schizoaffective
disorder.

- Current diagnosis of comorbid major depressive disorder, anxiety disorder or dysthymia
or any controlled (i.e. requires pharmacological treatment) comorbid diagnosis.
Participants with uncontrolled depressive or anxiety disorders may participate if, in
the opinion of the Principal Investigator, the disorder will not confound the results
of efficacy or safety assessments, increase risk to the participant or lead to
difficulty complying with the protocol.

- Meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or
dependence disorder.

- Have organic brain disease (such as dementia) or traumatic brain injury residua. Have
a history of seizure disorder (other than febrile seizures) or participants who have
taken (or are currently taking) anticonvulsants for seizure control.

- Females who are currently pregnant or breast feeding, and women of child-bearing
potential who are not currently using an adequate form of birth control.

- Participants with clinically significant abnormalities in ECG results that are deemed
exclusionary in the opinion of the Principal Investigator will not be allowed in the
trial.

- Participants who work the night shift or another schedule that would preclude
beginning the daily dose of study medication in the morning.

- Participants with a positive urine drug result at Screening.

- Medical conditions limiting participation in the study.

- Documented history of intolerance or non-responsivity to methylphenidate or
amphetamines.

- Have a medical condition that would, in the opinion of the study physician, make
participation medically hazardous.

- ADHD, Not Otherwise Specified

- History of surgery involving metal implants, metal fragments in the eyes, braces, or a
pacemaker.
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Jeffrey Newcorn, MD
Phone: 212-241-8012
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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mi
from
New York, NY
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