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

Completed

• Conditions: ADHD
• Interventions: Drug: Placebo; Drug: Vayarin

• Registration Number: NCT02473419
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Status Verified: 2017-03
• Primary Completion: 2017-03-02
• Study Completion: 2017-03-02
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo x 16 weeks
Vayarin and Placebo	Placebo	Placebo x 8 weeks and then Vayarin x 8 weeks
Vayarin	Vayarin	Vayarin x 16 weeks
Vayarin and Placebo	Vayarin	Placebo x 8 weeks and then Vayarin x 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in the emotional go/no-go task	Baseline and 16 weeks	Change in the emotional go/no-go task performed in the fMRI scanner at 16 weeks as compared to baseline

Secondary Outcome Measures

Name	Time	Method
Change in the resting state fMRI	Baseline and 16 weeks	Change in the resting state fMRI at 16 weeks as compared to baseline

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States