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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ADHD

Intervention / Treatment
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* Drug: Vayarin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vayarin<br>Vayarin x 16 weeks | Drug: Vayarin<br> <br> |
| Placebo<br>Placebo x 16 weeks | Drug: Placebo<br> <br> |
| Vayarin and Placebo<br>Placebo x 8 weeks and then Vayarin x 8 weeks | Drug: Vayarin<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the resting state fMRI | Change in the resting state fMRI at 16 weeks as compared to baseline | Baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical food, ADHD, Vayarin, Fish Oil