Neuroimaging, Omega-3 and Reward in Adults With ADHD (NORAA) Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02156089|
Recruitment Status : Terminated
First Posted : June 5, 2014
Last Update Posted : December 26, 2018
- 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.
- To learn more about how omega-3 fats affect brain activity and ADHD symptoms.
- Adults age 18 55 with ADHD symptoms.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder Attention Deficit Hyerpactivity Disorder||Other: Highly unsaturated omega-3 fatty acids||Phase 2|
Both attention deficit hyperactivity disorder (ADHD) and addictive behaviors have been persistently related to impaired reward-related processes in the ventral striatum as evidenced by functional magnetic resonance imaging studies (fMRI). These impairments characterized by decreased BOLD activation are thought to be linked to dopamine pathways including decreased D2 receptor function. Omega-3 highly unsaturated fatty acids (HUFAs) are critical for cell-signaling among other complex functions throughout the central nervous system. Animal models have demonstrated that depriving animals of the omega-3 DHA in utero significantly decreases the density of ventral striatal D2- like receptors and furthermore depletes dopamine in the nucleus acumens by 40-60%. The behavioral profile of animals subjected to dietary induced deficiencies of omega-3 reflect decreased goal-directed behavior and increased goal-irrelevant activity, hyperactivity, increased anxiety and reduced behavior flexibility. Abnormally low levels of omega-3 HUFAs have been persistently reported in the erythrocytes of both children and adults with ADHD while supplementation with omega-3 HUFAs was found in a meta-analysis of 10 clinical trials to improve symptoms of ADHD. However, to date no one has tested the potential mediating effects of omega-3 supplementation in reward-related processes in adults with ADHD using neuroimaging techniques. There is hence a need to research the potential treatment effects of omega-3 on assessments of brain function. Therefore, the primary objective of this study is to test the effects of omega-3 intervention (compared to a placebo) in increasing ventral striatal activation during the monetary incentive delay (MID) task. Secondary objectives include collecting neuroimaging data and standardized questionnaires measuring, mood, quality of life and symptoms of ADHD.
150 adults, other-wise healthy, aged 18-55 with ADHD.
The active group will be stratified according to age and sex to either an active intervention group receiving (1) 3000 mg of omega-3 HUFA smoothie or a placebo group (2) 3000 mg of smoothie macadamia nut oil for 16 weeks. After enrollment and baseline testing, active participants will be randomized to either the treatment or placebo group and instructed to begin consumption of assigned emulsions. Randomized participants will be assessed at baseline, 1 month, 8 weeks, and 16 weeks.
The primary outcome assessments will measure ventral-striatum activation during the MID task. Secondary objectives include: structural MRI, symptoms of ADHD using the Conner s Adult ADHD Rating Scales; negative affective symptoms; endocannabinoid levels and weight change.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Neuroimaging Omega-3 and Reward in Adults With ADHD (NORAA) Trial|
|Study Start Date :||June 4, 2014|
|Actual Primary Completion Date :||December 21, 2018|
|Actual Study Completion Date :||December 21, 2018|
- Other: Highly unsaturated omega-3 fatty acids
Nitrient - Matched Placebo of 3 g/d of macademia nut oil (in comparison to 3 g/d of omega-3 highly unsaturated fatty acids).
- To test if omega-3 HUFA intervention results in greater ventral-striatal activation during a reward task in adults with ADHD compared to a placebo group between baseline and follow up at 16 weeks. [ Time Frame: baseline and afte 15 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156089
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Joseph R Hibbeln, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|