Neuroimaging, Omega-3 and Reward in Adults With ADHD (NORAA) Trial

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Disorder, Attention Deficit Hyerpactivity Disorder

In brief

Background: \- People with attention-deficit hyperactivity disorder (ADHD) often have problems with motivation and rewards. . Omega-3 fats have helped symptoms of ADHD improve in children. Researchers want to learn more about the brain activity of people with ADHD and see how taking omega-3 fats might help. Objective: \- To learn more about how omega-3 fats affect brain activity and ADHD symptoms. Eligibility: \- Adults age 18 55 with ADHD symptoms. Design: * Participants will be screened with medical history and review of medical records. * For study visit 1, participants will have a medical examination and be interviewed to confirm they have ADHD. They will have an IQ test and give blood and urine samples. Height, weight, and blood pressure will be measured. They will also need to sign consent to agree to take part in the study. They will be asked to complete a food diary for 4 days * For visit 2, participants will give a blood sample. They will complete questionnaires about their mood and ADHD symptoms.. They may give a blood or saliva sample for genetic testing. * Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides in and out of a metal cylinder. It makes loud noises; participants will get earplugs. This scan examines the structure of the brain. * Participants will have a functional MRI scan. This scan measures the function of the brain while the volunteer is performing tasks in the scanner. They will stop ADHD medications 48 hours before this scan. * Participants will receive key-lime flavored omega-3 smoothie mix or placebo to takeevery day * For visit 3, participants will give blood samples and complete questionnaires. * For visit 4, participants will be weighed and have a blood test and MRI scans as per before. They will repeat the questionnaires and will guess whether they received the omega-3 or placebo.

Key facts

Study ID

NCT02156089

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

63

Starts

2014-06-04

Expected to finish

2018-12-21

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any medical illness or treatment that in the view of the investigators would compromise participation in research or participant safety, as determined by medical history, physical examination, laboratory tests (see details under Screening measures below), including, but not limited to:
• Unstable medical conditions requiring immediate intervention.
• Unstable or rapidly progressive neurological diseases.
• History hemorrhagic or ischemic stroke within the last 3 months.
• Known heart disease.
• Hypertension.
• Asthma
• If the participant is related to the study investigator or their superior, subordinate, or immediate family member.
• HIV positive.
• Significant dietary limitations:
• Allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish..
• Allergy, hypersensitivity, or intolerance to Macadamia nuts or any nuts such as almonds, walnuts, pecans, peanuts, etc.
• Pregnancy or breastfeeding (by urine pregnancy test; self-report).
• Reported consumption of fish and seafood three or more times per week within the last three months.
• Regular consumption of omega-3 supplements (e.g., cod liver oil, borage oil, fish oil or evening primrose oil) , defined as an average of 250 mg/day of omega-3 HUFAs over the previous 3 months.
• Severe alcohol or substance use disorder according to the AUDIT.
• Acute intoxication or withdrawal from alcohol or other CNS active substances to the extent that they may impair capacity to provide informed consent or participate in research.
• Some neuropsychiatric disorders are either so rare or associated with such profound alterations of brains structure and function that they will be excluded. This includes a diagnosis of severe Bipolar disorders or Axis 1 psychotic disorder assessed by SCID, including schizophrenia, psychosis NOS, autism, substance dependence; dementia, eating disorder.
• Cognitive impairment severe enough to preclude informed consent or valid responses on self-report questionnaires.
• Behavioral instability significant enough to impair ability for consent and participation.
• Participation in other research studies that in the opinion of the investigators would interfere with study outcomes or study compliance.
• On any of the following medications: Atomoxetine (Strattera), bupropion (Wellbutrin), tricyclic antidepressants (imipramine), alpha adrenergic agonists (clonidine, guanfacine) or modafinil (Provigil) depending whether dose interferes with scan and whether or not patient can stay on same dose throughout study.
• Use of non-steroidal anti-inflammatory drugs (NSAIDs), dalteparin, dipyrdamole, enoxaparin, ticlopedine, more than once per week within the last three months.
• Living situation unsuitable for the storage or use of intervention materials.
• MRI Exclusion Criteria:

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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