ADHDVAYA-fMRINCT02473419
Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment
An observational study of ADHD, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ADHD
- What is being tested?
- Vayarin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 2 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be subjects participating in a Vayarin clinical trial being conducted at NYU and The Medical Research Network in NYC.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Vayarin, Placebo
- Keywords
- Medical food, ADHD, Vayarin, Fish Oil
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VayarinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vayarin | Vayarin x 16 weeks Receives: Drug: Vayarin | |
| Placebo | Placebo x 16 weeks Receives: Drug: Placebo | |
| Vayarin and Placebo | Placebo x 8 weeks and then Vayarin x 8 weeks Receives: Drug: Vayarin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 16 weeks
Secondary outcomes (1)
Change in the resting state fMRI
Change in the resting state fMRI at 16 weeks as compared to baseline
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Enzymotec, The Medical Research Network
- Responsible party
- Sponsor
- Investigators
- Jeffrey Newcorn, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473419
- Sponsor's protocol ID
- GCO 15-0399
- Acronym
- VAYA-fMRI
- Status last verified
- Mar 2017
- First submitted
- 12 Jun 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment
- ClinicalTrials.gov ID
- NCT02473419
- Acronym / sponsor ID
- VAYA-fMRI / GCO 15-0399
- Conditions
- ADHD
- Keywords
- Medical food, ADHD, Vayarin, Fish Oil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- New York University, Enzymotec, The Medical Research Network
- Study start
- May 2015
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vayarin | – | Drug: VayarinVayarin x 16 weeks |
| Placebo | – | Drug: PlaceboPlacebo x 16 weeks |
| Vayarin and Placebo | – | Drug: Vayarin, Drug: PlaceboPlacebo x 8 weeks and then Vayarin x 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be subjects participating in a Vayarin clinical trial being conducted at NYU and The Medical Research Network in NYC.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vayarin | Drug | Vayarin, Vayarin and Placebo |
| Placebo | Drug | Placebo, Vayarin and Placebo |
Primary outcome
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
1 secondary outcome
Change in the resting state fMRI
Time frame: Baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Newcorn, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the emotional go/no-go task (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.