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Completed

NCT Number: NCT02473419

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vayarin

Drug

Placebo

Drug

Primary outcomes

  1. Change in the emotional go/no-go task

    Time frame: 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 outcomes

  1. Change in the resting state fMRI

    Time frame: Baseline and 16 weeks

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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Enzymotec
  • New York University
  • The Medical Research Network

Registry information

Acronym: VAYA-fMRI

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2015
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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