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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02473419

Acronym

VAYA-fMRI

Enrollment

107

Registered

2015-06-16

Start date

2015-05-31

Completion date

2017-03-02

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

Medical food, ADHD, Vayarin, Fish Oil

Brief summary

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.

Detailed 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.

Interventions

DRUGVayarin

DRUGPlacebo

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in the emotional go/no-go task	Baseline and 16 weeks	Change in the emotional go/no-go task performed in the fMRI scanner at 16 weeks as compared to baseline

Secondary

Measure	Time frame	Description
Change in the resting state fMRI	Baseline and 16 weeks	Change in the resting state fMRI at 16 weeks as compared to baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026