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NCT02156089 · ClinicalTrials.gov registry record · Phase 2
Neuroimaging, Omega-3 and Reward in Adults With ADHD (NORAA) Trial
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT02156089 is a Phase 2 study that was terminated before completion, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 63 participants.
The verdict
NCT02156089, a Phase 2 study, was terminated before completion, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Highly unsaturated omega-3 fatty acids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2014-06-04 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02156089
The ClinicalTrials.gov registry entry for NCT02156089 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Highly unsaturated omega-3 fatty acids is the first listed.
NCT02156089 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02156089 about?
NCT02156089 is a clinical study titled "Neuroimaging, Omega-3 and Reward in Adults With ADHD (NORAA) Trial". 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 mi...
What is the current status of trial NCT02156089?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2014-06-04. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT02156089?
The interventions under investigation include: Highly unsaturated omega-3 fatty acids (OTHER).
Who is sponsoring clinical trial NCT02156089?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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