ADHDOMNeADHDNCT07364331
Omega-3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder (OMNeADHD)
A study testing Omega-3 in people with ADHD and Children, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- ADHD, Children, Adolescents
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Sep 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- DSM-5 diagnosis of ADHD
- Did not have any changes of ADHD treatment (pharmacological/psychological) within 4 weeks of entering the trial.
- SNAP-IV inattention subscale >=12, or hyperactivity subscale >=12, or inattention+ hyperactivity subscales >=24
Who cannot join
- IQ<80
- Allergic to omega-3
- Physical disorders: thyroid function, cancer
- Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Pei-Chen Chang, PhD, 886 4 22052121, 013121@tool.caaumed.org.tw
Pei-chen Chang, PD
About this study
Official title: Omega- 3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder With (OMNeADHD) A Double Blind Randomized Controlled Trial of High Dose Omega- 3 Fatty Acids in Children and Adolescents With ADHD With Omega- 3 Deficiency.
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.
Read the detailed description
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids (EPA or DHA) in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.
- Conditions
- ADHD, Children, Adolescents
- Being tested
- Omega-3, Placebo
- Keywords
- omega-3, epa, dha, children, ADHD, adolescents
- 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-3Dietary supplement
EPA or DHA
PlaceboDietary supplement
olive oil
| Study group | Role | What they receive |
|---|---|---|
| omega-3 fatty acids: EPA | Active comparator | EPA Receives: Dietary Supplement: Omega-3 |
| omega-3 fatty acids: DHA | Active comparator | DHA Receives: Dietary Supplement: Omega-3 |
| placebo | Placebo comparator | olive oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms-attention and impulsivity symptom severity
The Swanson, Nolan, and Pelham Rating Scale- 4th edition (SNAP-IV) is used to help assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.
Measured: week 0,1,2,4,8,12
Secondary outcomes (2)
Measurement of cognitive function: attention and impulsivity
The Continuous Performance Test (CPT) will be used to measure attention and impulse control of the subjects. During the test, individuals are presented with a series of stimuli and must respond to specific targets while ignoring distractions. It is commonly used to assess attention deficits and impulsivity, key symptoms in ADHD.
Measured: week 0,12
Concentration of Peripheral cortisol levels
saliva and blood samples will be taken to assess peripheral cortisol levels. (micrograms/deciliter, μg/dL)
Measured: week 0,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start4 Sep 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Model description
- This is a 12 week study to investigate the effects of EPA, DHA and placebo in youth with ADHD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Chen Chang, China Medical University Hospital
- Investigators
- Pei-Chen Chang, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364331
- Sponsor's protocol ID
- CMUH110-REC3-203
- Acronym
- OMNeADHD
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega- 3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder With (OMNeADHD) A Double Blind Randomized Controlled Trial of High Dose Omega- 3 Fatty Acids in Children and Adolescents With ADHD With Omega- 3 Deficiency.
- ClinicalTrials.gov ID
- NCT07364331
- Acronym / sponsor ID
- OMNeADHD / CMUH110-REC3-203
- Conditions
- ADHD, Children, Adolescents
- Keywords
- omega-3, epa, dha, children, ADHD, adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- 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.
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.
Detailed description
This is a 12 week randomized controlled study on the effects of omega-3 fatty acids (EPA or DHA) in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 12 week study to investigate the effects of EPA, DHA and placebo in youth with ADHD
| Arm | Type | Receives |
|---|---|---|
| omega-3 fatty acids: EPA | Active comparator | Dietary Supplement: Omega-3EPA |
| omega-3 fatty acids: DHA | Active comparator | Dietary Supplement: Omega-3DHA |
| placebo | Placebo comparator | Dietary Supplement: Placeboolive oil |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- DSM-5 diagnosis of ADHD
- Did not have any changes of ADHD treatment (pharmacological/psychological) within 4 weeks of entering the trial.
- SNAP-IV inattention subscale >=12, or hyperactivity subscale >=12, or inattention+ hyperactivity subscales >=24
Key exclusion criteria (4 listed)
- IQ<80
- Allergic to omega-3
- Physical disorders: thyroid function, cancer
- Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive 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 |
|---|---|---|
| Omega-3EPA or DHA | Dietary supplement | omega-3 fatty acids: DHA, omega-3 fatty acids: EPA |
| Placeboolive oil | Dietary supplement | placebo |
Primary outcome
Clinical symptoms-attention and impulsivity symptom severity
Time frame: week 0,1,2,4,8,12
The Swanson, Nolan, and Pelham Rating Scale- 4th edition (SNAP-IV) is used to help assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.
2 secondary outcomes
Measurement of cognitive function: attention and impulsivity
Time frame: week 0,12
Concentration of Peripheral cortisol levels
Time frame: week 0,12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Pei-Chen Chang, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with ADHD and Children, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Chen Chang, PhD (+88622052121 ext. 14126, 013121@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptoms-attention and impulsivity symptom severity (time frame: week 0,1,2,4,8,12). 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 26 Jan 2026.