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

Completed · Phase 4

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT01924429

Run by

Jeffrey Newcorn

People needed

30

Starts

2013-03-01

Expected to finish

2013-12-01

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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