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

This is an interventional other trial for Attention Deficit Disorder focused on measuring fMRI, Reward Processing, Nutrition, Omega-3 Fatty Acids, ADHD Read More

• INCLUSION CRITERIA:

Participants will be 18 or over and up to 55 years old.

• In general good health.
• Body Mass Index (BMI) between 18 and 35.
• Able to come to the NIH clinical center for each of their scheduled appointments for the duration of the study and have a working phone number.
• Able to understand the consent form and provide written informed consent.
• Have an IQ of 70 or greater as assessed by the WASI for fast IQ testing (a score of less than this is considered to have global intellectual disability - classified in DSM-IV as mental retardation). There are often issues around the ability to give informed consent in adults with global intellectual disability.
• Meet DSM diagnostic criteria for ADHD as assessed by the CAADID Conners Adult ADHD Diagnostic Interview for DSM-IV.
• Have significant symptoms of ADHD despite concurrent pharmacological and psychological therapies as assessed by the Connors Adult ADHD rating scale (CAARS) (as assessed at telephone screen).
• Be willing to have a 48hour wash-out of stimulant medication prior to both baseline and follow-up scans.
• Willing to stop all nutritional supplements including omega-3 fats.
• Willing to stop eating seafood for the study duration of 16 weeks.
• Be willing to have 2 MRI scanning sessions.
• People who are willing to take the smoothie emulsion every day for 16 weeks.

EXCLUSION CRITERIA:

• 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:

• Have ferromagnetic objects in their bodies, which might be adversely affected by MRI (e.g., surgical clips, metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear or eye implant). Any doubt about presence of these objects will result in exclusion from this study.
• Extreme claustrophobia.
• Left-handed individuals.