Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
Brief summary
The aim of the study is to provide preliminary data on the relationship of Essential Fatty
Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural
functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This
main aim will be achieved in two ways. First the investigators will measure the relationship
of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the
potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and
behavioural measures in ADHD cases will be investigated. We will evaluate the extent to
which changes in neuronal activity and cognitive performance are related to behavioural and
functional measures over time. This is to be carried out by conducting a randomised
controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and
Cognitive Effects in Adult Neurodevelopment).
The study design will be a 6-month double blind placebo control study with a group of 80
adults with a diagnosis of ADHD. The group will be divided into 40 participants who receive
EFA dietary supplements and 40 who receive placebo, over a 6-month period. Allocation to EFA
dietary supplementation and placebo groups will be randomly allocated and blind to both the
investigator and participants. In addition a sample of 30 controls will take part in
baseline levels of assessment and be used for case-control comparisons to investigate the
links between EFA blood levels and cognitive-electrophysiological function at one time
point.
The study design will enable preliminary data to address the following hypotheses:
1. Changes in cognitive and electrophysiological function (neuronal activity) will be
found following supplementation with dietary EFAs.
2. Changes in cognition and/or brain activity will be related to blood levels of EFAs.
3. Changes in cognitive performance and electrophysiological parameters will correlate
with behavioural function, affective regulation or functional impairments.
4. At baseline, case-control differences in EFA blood-levels will be found which will be
linked to cognitive and electrophysiological function.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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