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

NCT ID: NCT02473419

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-03-02

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.

Conditions

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ADHD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Vayarin

Vayarin x 16 weeks

Vayarin

Intervention Type DRUG

Placebo

Placebo x 16 weeks

Placebo

Intervention Type DRUG

Vayarin and Placebo

Placebo x 8 weeks and then Vayarin x 8 weeks

Vayarin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Vayarin

Intervention Type DRUG

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York University

OTHER

Sponsor Role collaborator

Enzymotec

INDUSTRY

Sponsor Role collaborator

The Medical Research Network

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Newcorn, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 15-0399

Identifier Type: -

Identifier Source: org_study_id

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