ADHDOMIMYDepNCT07363551
Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression
A study testing Omega-3 fatty acids in people with ADHD, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- ADHD
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jun 2021to 31 May 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth with a DSM-5 diagnosis of MDE
Who cannot join
- Has a recent change in antidepressants or psychotherapy treatment within 4 weeks.
- Allergic to omega-3 fatty acids
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
Taichung, Taichung, 404
Pei-Chen Chang, MD, Master, 886 4 22052121, 013121@tool.caaumed.org.tw
Pei-Chen Chang, MD
About this study
Official title: Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression (OMIMYDep)- A Double-blind Randomized Controlled Trial
This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder
Read the detailed description
This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder. Outcome measures including clinical symptoms, inflammation biomarkers and gut microbiota profiles.
- Conditions
- ADHD
- Being tested
- Omega-3 fatty acids, Placebo
- Keywords
- omega-3, ADHD
- 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 acidsCombination product
omega-3 fatty acids (EPA)
PlaceboDietary supplement
soy bean oil
| Study group | Role | What they receive |
|---|---|---|
| omega-3 | Active comparator | EPA Receives: Combination Product: Omega-3 fatty acids |
| placebo | Placebo comparator | soy bean oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical symptoms
Hamilton Depression Rating Scale (HAMD)-21 item is a clinician-rated scale designed to assess the severity of depressive symptoms over the past week. It is commonly used in clinical trials and psychiatric practice Total Score Interpretation (Commonly Used) Total Score and Severity Level
- 0-7: No depression / Normal
- 8-13: Mild depression
- 14-18: Moderate depression
- 19-22: Severe depression -≥23: Very severe depression
Measured: week 0,1,2,4,8,12
Secondary outcomes (2)
gut microbiota
gut microbiota
Measured: week 0,12
inflammatory cytokines (IL-6, hsCRP)
blood inflammatory cytokines
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 start9 Jun 2021
- Primary completion31 May 2026 (estimated)
- Study completion31 May 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
- To investigate the effects of omega-3 in youth with depression
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363551
- Sponsor's protocol ID
- CMUH109-REC3-129
- Acronym
- OMIMYDep
- 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
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, Inflammation, Gut Microbiota in Youth With Depression (OMIMYDep)- A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07363551
- Acronym / sponsor ID
- OMIMYDep / CMUH109-REC3-129
- Conditions
- ADHD
- Keywords
- omega-3, ADHD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 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 double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder
Detailed description
This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder. Outcome measures including clinical symptoms, inflammation biomarkers and gut microbiota profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To investigate the effects of omega-3 in youth with depression
| Arm | Type | Receives |
|---|---|---|
| omega-3 | Active comparator | Combination Product: Omega-3 fatty acidsEPA |
| placebo | Placebo comparator | Dietary Supplement: Placebosoy bean oil |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Youth with a DSM-5 diagnosis of MDE
Key exclusion criteria (2 listed)
- Has a recent change in antidepressants or psychotherapy treatment within 4 weeks.
- Allergic to omega-3 fatty acids
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 acidsomega-3 fatty acids (EPA) | Combination product | omega-3 |
| Placebosoy bean oil | Dietary supplement | placebo |
Primary outcome
clinical symptoms
Time frame: week 0,1,2,4,8,12
Hamilton Depression Rating Scale (HAMD)-21 item is a clinician-rated scale designed to assess the severity of depressive symptoms over the past week. It is commonly used in clinical trials and psychiatric practice Total Score Interpretation (Commonly Used) Total Score and Severity Level * 0-7: No depression / Normal * 8-13: Mild depression * 14-18: Moderate depression * 19-22: Severe depression -≥23: Very severe depression
2 secondary outcomes
gut microbiota
Time frame: week 0,12
inflammatory cytokines (IL-6, hsCRP)
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.
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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.
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 fatty acids in people with ADHD, 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 1 inclusion and 2 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical symptoms (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.