NCT02473419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

June 12, 2015

Last Update Submit

March 24, 2017

Conditions

ADHD

Keywords

Medical foodADHDVayarinFish Oil

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in the resting state fMRI

    Baseline and 16 weeks

Study Arms (3)

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: VayarinDrug: Placebo

Interventions

VayarinDRUG
VayarinVayarin and Placebo
PlaceboDRUG
PlaceboVayarin and Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jeffrey Newcorn, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

May 1, 2015

Primary Completion

March 2, 2017

Study Completion

March 2, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)