Adult Attention Deficit Hyperactivity DisorderPhase 3OCEAN-GERNCT01798381
Essential Fatty Acids in Adult ADHD
A Phase 3 study testing Essential fatty acids in people with Adult Attention Deficit Hyperactivity Disorder, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Attention Deficit Hyperactivity Disorder
- What is being tested?
- Essential fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Dec 2015
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-IV ADHD
Who cannot join
- any acute psychiatric disorder
Trial locations and contacts
1 site in 1 country.
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
The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).
- Being tested
- Essential fatty acids
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential fatty acidsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Essential fatty acids | Active comparator | Omega-3 Receives: Dietary Supplement: Essential fatty acids |
| Placebo | Placebo comparator | Placebo tablet Receives: Dietary Supplement: Essential fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
Psychopatholoy of adult ADHD
Measured: 6 months
Secondary outcomes (1)
Short and long interval cortical inhibition (SICI and LICI)
Motoric evoced potentials by transcranial magnetic stimulation (TMS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rösler, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798381
- Sponsor's protocol ID
- OCEAN-GER
- Acronym
- OCEAN-GER
- Status last verified
- Oct 2020
- First submitted
- 19 Feb 2013
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. 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
- NCT01798381
- Acronym / sponsor ID
- OCEAN-GER / OCEAN-GER
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Feb 2013 (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.
The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential fatty acids | Active comparator | Dietary Supplement: Essential fatty acidsOmega-3 |
| Placebo | Placebo comparator | Dietary Supplement: Essential fatty acidsPlacebo tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- DSM-IV ADHD
Key exclusion criteria (1 listed)
- any acute psychiatric disorder
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 |
|---|---|---|
| Essential fatty acids | Dietary supplement | Essential fatty acids, Placebo |
Primary outcome
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
Time frame: 6 months
Psychopatholoy of adult ADHD
1 secondary outcome
Short and long interval cortical inhibition (SICI and LICI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Essential fatty acids in people with Adult Attention Deficit Hyperactivity Disorder, run by Universität des Saarlandes at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Oct 2020. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) (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 29 Oct 2020.