The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— OCEAN  

Official title:

The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01750307
• Other study ID #: OCEAN protocol
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2012
• Last updated: December 17, 2012
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: December 2012
• Source: King's College London
• Contact: Ruth E Cooper
• Phone: +44 207 848 5401
• Email: ruth.cooper[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: King's College London
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Cases:

• Clinical diagnosis of ADHD (combined or inattentive type)

• Controls:

• Screen below threshold for ADHD

Exclusion Criteria:

• Cases:

• Autism spectrum disorder

• Recurrent major depression

• Bipolar I disorder

• Psychotic disorders

• Obsessive compulsive disorder

• Learning difficulties (IQ < 80)

• Neurological problems

• Drug abuse

• Those who are already taking EFA supplements

• Metabolic conditions

• Infectious diseases

• Controls:

• ADHD

• All other exclusion criteria for cases as above

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Dietary Supplement:
• Experimental fatty acid supplementation
4 x capsules per day. Daily dose: 1584mg EFA
• Placebo comparator: MCT oil softgel
4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill

Locations

Country	Name	City	State
United Kingdom	Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function	Brain function will be measured using direct current (DC) electroencephalography (EEG) in participants first while they are at rest and second during 4 cognitive tasks. Behavioural function will be measured through assessment of reading and spelling, emotional lability, ADHD symptoms and other self-ratings of behaviour (such as executive function). These measures will be related to the effect of dietary supplementation and blood levels of EFAs in adults with ADHD.	6 months	No
Secondary	The relationship of essential fatty acids to ADHD	This will be assessed by recording blood levels of EFAs in cases and controls at baseline assessment.	0 months	No