- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07711444
The Efficacy of Long-Chain Fatty Acids, Eicosapentaenoic Acid (EPA) and Specialized Pro-Resolving Mediators (SPMs), in Treating Long COVID Neuropsychiatric Symptoms
July 20, 2026 updated by: Kuan-Pin, National Science and Technology Council, Taiwan
Eicosapentaenoic Acid and Specialized Pro-Resolving Mediator for Depressive Symptoms in Long COVID: A Randomized Controlled Trial
Researchers conducted a 12-week, double-blind, randomized, placebo-controlled trial to assess the effectiveness of EPA or SPM treatments versus a placebo in managing Long COVID symptoms in adult patients.
Researchers planned to enroll 240 eligible participants from various general and psychiatric hospitals in Taiwan.
The focus was on evaluating the therapeutic impact and potential side effects of administering 3 g/day of EPA or 1.67 mg/day of SPMs on symptoms of depression in these patients.
This consolidated approach aims to provide comprehensive insights into the efficacy of EPA and SPM treatments in Long COVID cases, addressing crucial mental health aspects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taichung
-
Taichung, Taichung, Taiwan, 404
- Mind-Body Interface Research Center (MBI Lab & Care)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Confirmed SARS-CoV-2 infection by PCR, documented positive test, or clinician diagnosis
- Meeting CDC criteria for Post-COVID Conditions (Long COVID) as the presence of new, returning, or ongoing symptoms ≥4 weeks after confirmed SARS-CoV-2 infection
- Hamilton Depression Rating Scale (HAMD-21) score ≥18 at baseline
- Stable antidepressant treatment for ≥4 weeks or no current antidepressant use; and
- Ability to provide written informed consent
Exclusion Criteria:
- Current or past six-month diagnosis of psychotic disorder, bipolar disorder, substance use disorder, or other major psychiatric conditions based on ICD-10 or DSM-5 criteria
- Significant neurological or medical comorbidities (eg, epilepsy, traumatic brain injury, autoimmune disease, cancer), acute infections, or clinically significant laboratory abnormalities
- Regular use of SPM or EPA supplementation >0·5 g/day
- Known allergy or intolerance to omega-3 fatty acids or SPMs; and
- Requirement for inpatient psychiatric care due to acute suicide risk
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eicosapentaenoic acid (EPA)
Eicosapentaenoic acid (EPA) at a total daily dose of 3 g, administered as six capsules
|
A total daily dose of 3 g, administered as six capsules
Other Names:
|
|
Experimental: Specialized pro-resolving mediators (SPMs)
SPM at a total daily dose of 1.67 g, administered as six capsules
|
A total daily dose of 1.67 g, administered as six capsules
Other Names:
|
|
Placebo Comparator: Placebo
soybean oil
|
Six capsules containing soybean oil daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamilton Depression Rating Scale (HAMD)
Time Frame: (week 0) and at weeks 1, 2, 4, 8, and 12
|
Adult depressive symptoms were assessed using the 21-item HAMD at baseline (week 0) and at weeks 1, 2, 4, 8, and 12.
|
(week 0) and at weeks 1, 2, 4, 8, and 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Erythrocyte Omega-3 Polyunsaturated Fatty Acids
Time Frame: Week 0 and Week 12
|
Peripheral blood samples were collected at baseline and at the end of the 12-week intervention period using EDTA-containing tubes for erythrocyte fatty acid analysis
|
Week 0 and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
June 1, 2026
Study Registration Dates
First Submitted
July 14, 2026
First Submitted That Met QC Criteria
July 14, 2026
First Posted (Actual)
July 17, 2026
Study Record Updates
Last Update Posted (Actual)
July 21, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Behavior
- COVID-19
- Depression
- Fatty Acids
- Lipids
- Eicosanoids
- Fatty Acids, Unsaturated
- Oils
- Dietary Fats
- Fats
- Dietary Fats, Unsaturated
- Fish Oils
- Eicosapentaenoic Acid
- Fatty Acids, Omega-3
Other Study ID Numbers
- CMUH113-REC2-158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.