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

March 24, 2017 updated by: Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be subjects participating in a Vayarin clinical trial being conducted at NYU and The Medical Research Network in NYC.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vayarin
Vayarin x 16 weeks
Drug: Vayarin
Placebo
Placebo x 16 weeks
Drug: Placebo
Vayarin and Placebo
Placebo x 8 weeks and then Vayarin x 8 weeks
Drug: Placebo
Drug: Vayarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

New York University
The Medical Research Network
Enzymotec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 2, 2017

Study Completion (Actual)

March 2, 2017

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GCO 15-0399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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