Attention Deficit Hyperactivity Disorder (ADHD)OCEANNCT01750307
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
A study testing Experimental fatty acid supplementation in people with Attention Deficit Hyperactivity Disorder (ADHD), run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Experimental fatty acid supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cases:
- Clinical diagnosis of ADHD (combined or inattentive type)
- Controls:
- Screen below threshold for ADHD
Who cannot join
- Cases:
- Autism spectrum disorder
- Recurrent major depression
- Bipolar I disorder
- Psychotic disorders
- Obsessive compulsive disorder
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London
London, London, SE58AF
Ruth E Cooper, +44 207 848 5401, ruth.cooper@kcl.ac.uk
Rose Scott, +44 207 848 5712, rose.scott@kcl.ac.uk
About this study
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).
Read more
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:
- Changes in cognitive and electrophysiological function (neuronal activity) will be found following supplementation with dietary EFAs.
- Changes in cognition and/or brain activity will be related to blood levels of EFAs.
- Changes in cognitive performance and electrophysiological parameters will correlate with behavioural function, affective regulation or functional impairments.
- At baseline, case-control differences in EFA blood-levels will be found which will be linked to cognitive and electrophysiological function.
- Being tested
- Experimental fatty acid supplementation, Placebo comparator: MCT oil softgel
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Essential fatty acids (EFAs), Electroencephalography (EEG), Event-related potential (ERP), Omega 3, Randomised Control Trial, Fish oil, Supplementation, Reading, Spelling, Behaviour, Emotional lability
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental fatty acid supplementationDietary supplement
Also called Essential fatty acid: Eye Q triple (product code: FO-5274ART)
4 x capsules per day. Daily dose: 1584mg EFA
Placebo comparator: MCT oil softgelDietary supplement
Also called MCT oil softgel (Product code: GL-5200ART)
4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill
| Study group | Role | What they receive |
|---|---|---|
| Fatty acid supplementation | Experimental | 4 capsules to be taken daily Receives: Dietary Supplement: Experimental fatty acid supplementation |
| Medium Chain Triglyceride (MCT) oil softgel | Placebo comparator | 4 capsules to be taken daily Receives: Dietary Supplement: Placebo comparator: MCT oil softgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Asherson, King's College London
- Investigators
- Philip Asherson, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750307
- Sponsor's protocol ID
- OCEAN protocol
- Acronym
- OCEAN
- Status last verified
- Dec 2012
- First submitted
- 12 Dec 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
- ClinicalTrials.gov ID
- NCT01750307
- Acronym / sponsor ID
- OCEAN / OCEAN protocol
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Essential fatty acids (EFAs), Electroencephalography (EEG), Event-related potential (ERP), Omega 3, Randomised Control Trial, Fish oil, Supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Changes in cognitive and electrophysiological function (neuronal activity) will be found following supplementation with dietary EFAs.
- Changes in cognition and/or brain activity will be related to blood levels of EFAs.
- Changes in cognitive performance and electrophysiological parameters will correlate with behavioural function, affective regulation or functional impairments.
- At baseline, case-control differences in EFA blood-levels will be found which will be linked to cognitive and electrophysiological function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatty acid supplementation | Experimental | Dietary Supplement: Experimental fatty acid supplementation4 capsules to be taken daily |
| Medium Chain Triglyceride (MCT) oil softgel | Placebo comparator | Dietary Supplement: Placebo comparator: MCT oil softgel4 capsules to be taken daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cases:
- Clinical diagnosis of ADHD (combined or inattentive type)
- Controls:
- Screen below threshold for ADHD
Key exclusion criteria (15 listed)
- Cases:
- Autism spectrum disorder
- Recurrent major depression
- Bipolar I disorder
- Psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental fatty acid supplementationAlso: Essential fatty acid: Eye Q triple (product code: FO-5274ART)4 x capsules per day. Daily dose: 1584mg EFA | Dietary supplement | Fatty acid supplementation |
| Placebo comparator: MCT oil softgelAlso: MCT oil softgel (Product code: GL-5200ART)4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill | Dietary supplement | Medium Chain Triglyceride (MCT) oil softgel |
Primary outcome
The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function
Time frame: 6 months
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.
1 secondary outcome
The relationship of essential fatty acids to ADHD
Time frame: 0 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Asherson principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental fatty acid supplementation in people with Attention Deficit Hyperactivity Disorder (ADHD), run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth E Cooper (+44 207 848 5401, ruth.cooper@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.