Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment (VAYA-fMRI)

Mount Sinai Health System

Status

Completed

Conditions

ADHD

Treatments

Drug: Placebo

Drug: Vayarin

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02473419

GCO 15-0399

Details and patient eligibility

About

The objective of this research is to use functional magnetic resonance imaging (fMRI) with a neuropsychological task to test the prefrontal mechanism of action of the medical food Vayarin.

Full description

The investigators 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 will be recruited from trials of Vayarin that are enrolling and treating participants at New York University and The Medical Research Network.

Enrollment

107 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects eligible to enroll in the Vayarin clinical study according to screening visit will be asked to participate in the fMRI study.
Must be willing and able to perform fMRI scanning
Must maintain compliance to their trials' protocols

Exclusion criteria

pre-existing medical or psychological condition that precludes scanning (e.g., claustrophobia, morbid obesity)
implanted medical device (e.g., pacemaker)
metal in the body that cannot be removed (e.g., braces)
pregnancy
concomitant use of anti-hypertensives or any other medications affecting the blood oxygenation level-dependent (BOLD) signal