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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by King's College London
Sponsor:
Information provided by (Responsible Party):
Philip Asherson, King's College London
ClinicalTrials.gov Identifier:
NCT01750307
First received: December 12, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.

Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD)
Dietary Supplement: Experimental fatty acid supplementation
Dietary Supplement: Placebo comparator: MCT oil softgel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The relationship of essential fatty acids to ADHD [ Time Frame: 0 months ] [ Designated as safety issue: No ]
    This will be assessed by recording blood levels of EFAs in cases and controls at baseline assessment.


Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fatty acid supplementation
4 capsules to be taken daily
Dietary Supplement: Experimental fatty acid supplementation
4 x capsules per day. Daily dose: 1584mg EFA
Other Name: Essential fatty acid: Eye Q triple (product code: FO-5274ART)
Placebo Comparator: Medium Chain Triglyceride (MCT) oil softgel
4 capsules to be taken daily
Dietary Supplement: Placebo comparator: MCT oil softgel
4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill
Other Name: MCT oil softgel (Product code: GL-5200ART)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750307

Contacts
Contact: Ruth E Cooper +44 207 848 5401 ruth.cooper@kcl.ac.uk
Contact: Rose Scott +44 207 848 5712 rose.scott@kcl.ac.uk

Locations
United Kingdom
Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London Recruiting
London, United Kingdom, SE58AF
Contact: Ruth E Cooper    +44 207 848 5401    ruth.cooper@kcl.ac.uk   
Contact: Rose Scott    +44 207 848 5712    rose.scott@kcl.ac.uk   
Principal Investigator: Philip Asherson         
Sub-Investigator: Ruth Cooper         
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Philip Asherson King's College London
  More Information

No publications provided

Responsible Party: Philip Asherson, Professor, King's College London
ClinicalTrials.gov Identifier: NCT01750307     History of Changes
Other Study ID Numbers: OCEAN protocol
Study First Received: December 12, 2012
Last Updated: December 17, 2012
Health Authority: United Kingdom: King's College London

Keywords provided by King's College London:
Essential fatty acids (EFAs)
Attention Deficit Hyperactivity Disorder (ADHD)
Electroencephalography (EEG)
Event-related potential (ERP)
Omega 3
Randomised Control Trial
Fish oil
Supplementation
Reading
Spelling
Behaviour
Emotional lability

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014