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

Icahn School of Medicine at Mount Sinai107 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

107

Conditions

ADHD

Interventions

VayarinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Change in the emotional go/no-go task

Change in the emotional go/no-go task performed in the fMRI scanner at 16 weeks as compared to baseline

Time frame: Baseline and 16 weeks

Secondary Outcomes

Change in the resting state fMRI

Change in the resting state fMRI at 16 weeks as compared to baseline

Time frame: Baseline and 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.