ADHDPhase 3NCT01777048
Omega-3 Fatty Acids Supplementation in ADHD
A Phase 3 study testing Omega-3 Fatty Acids Supplementation in people with ADHD, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Omega-3 Fatty Acids Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to May 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants between ages 6 and 12 years who:
- have been clinically diagnosed with ADHD by a physician
- meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
- are on stable dosage of methylphenidate treatment before the start of the study
- are able to speak English or German
Who cannot join
- Participants who are younger than 6 years old or older than 12 years old
- Those who have not been clinically diagnosed with ADHD by a physician
- Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ < 70)
- Those with titrated dosage of methylphenidate before the start of the study
Show all 10Show fewer
- Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
- Those with known hypersensitivity to the IMP under investigation
- Those who are unable to read and understand the parent/participant information
- Those receiving medications other than methylphenidate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitäre Psychiatrische Kliniken (UPK) Basel
Basel, 4058
About this study
Official title: Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder
The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
- Conditions
- ADHD
- Being tested
- Omega-3 Fatty Acids Supplementation, Omega-3 Placebo
- 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.
Omega-3 Fatty Acids SupplementationDietary supplement
Omega-3 PlaceboDietary supplement
Placebo capsules manufactured to mimic Omega-3 capsules
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | 1g of Omega-3 per day [400mg DHA \& 600mg EPA] for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner Receives: Dietary Supplement: Omega-3 Fatty Acids Supplementation |
| Omega-3 Placebo | Placebo comparator | 1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner Receives: Dietary Supplement: Omega-3 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD Rating Scale-IV total score
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (1)
Change in Child Behaviour Checklist total score
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Low recruitment numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Universitäre Psychiatrische Kliniken (UPK) Basel
- Responsible party
- Principal investigator, Yoon Phaik Ooi, University Hospital, Basel, Switzerland
- Investigators
- Yoon Phaik Ooi, PhD, Study director, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777048
- Sponsor's protocol ID
- 203/12
- Status last verified
- Jun 2015
- First submitted
- 16 Jan 2013
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
PubMed 37058600
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01777048
- Acronym / sponsor ID
- 203/12
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment numbers
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Universitäre Psychiatrische Kliniken (UPK) Basel
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 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 overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
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 |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | Dietary Supplement: Omega-3 Fatty Acids Supplementation1g of Omega-3 per day [400mg DHA \& 600mg EPA] for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner |
| Omega-3 Placebo | Placebo comparator | Dietary Supplement: Omega-3 Placebo1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- have been clinically diagnosed with ADHD by a physician
- meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
- are on stable dosage of methylphenidate treatment before the start of the study
- are able to speak English or German
Key exclusion criteria (10 listed)
- Participants who are younger than 6 years old or older than 12 years old
- Those who have not been clinically diagnosed with ADHD by a physician
- Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ < 70)
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 |
|---|---|---|
| Omega-3 Fatty Acids Supplementation | Dietary supplement | Omega-3 Fatty Acids |
| Omega-3 PlaceboPlacebo capsules manufactured to mimic Omega-3 capsules | Dietary supplement | Omega-3 Placebo |
Primary outcome
Change in ADHD Rating Scale-IV total score
Time frame: Baseline, Week 6, and Week 12
1 secondary outcome
Change in Child Behaviour Checklist total score
Time frame: Baseline and Week 12
Results and safety
The study was stopped early (reason given: Low recruitment numbers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 37058600Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
Related trials for ADHD
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
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.
Yoon Phaik Ooi, PhD study director
University of Basel
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 Omega-3 Fatty Acids Supplementation in people with ADHD, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Jun 2015. 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 Switzerland. 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 was stopped early (reason given: Low recruitment numbers). Results are not available in the source record.
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?
Change in ADHD Rating Scale-IV total score (time frame: Baseline, Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777048, which also lists 1 linked publication.
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 24 Jun 2015.