Neurobiological Basis of Response to Vayarin in Adults Wi... | NCT02473419

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

NCT02473419

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Mar 27, 2017Actual

Enrollment

107Actual

Phase

Not provided

Conditions

ADHD

Interventions

Vayarin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Mar 2, 2017Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

Jun 12, 2015

First Submission Date that Met QC Criteria

Jun 12, 2015

First Posted Date

Jun 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2017

Last Update Posted Date

Mar 27, 2017Actual

Name	Class
New York University	OTHER
Enzymotec	INDUSTRY
The Medical Research Network	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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: Vayarin Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vayarin	Drug		Vayarin Vayarin and Placebo
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Newcorn, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided