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

ADHD Clinical Trial

— VAYA-fMRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473419
• Other study ID #: GCO 15-0399
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: March 24, 2017
• Start date: May 2015
• Est. completion date: March 2, 2017

Study information

• Verified date: March 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Vayarin

• Placebo

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Enzymotec, New York University, The Medical Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the resting state fMRI	Change in the resting state fMRI at 16 weeks as compared to baseline	Baseline and 16 weeks