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Completed

NCT Number: NCT07711444

The Efficacy of Long-Chain Fatty Acids, Eicosapentaenoic Acid (EPA) and Specialized Pro-Resolving Mediators (SPMs), in Treating Long COVID Neuropsychiatric Symptoms

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.

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Key information

Conditions

COVID - 19 Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Depression - Major Depressive Disorder Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind-Body Interface Research Center (MBI Lab & Care)

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eicosapentaenoic acid (omega-3 fatty acid)

Dietary Supplement

A total daily dose of 3 g, administered as six capsules

Other names: EPA

Specialized Pro-Resolving Lipid Mediator

Dietary Supplement

A total daily dose of 1.67 g, administered as six capsules

Other names: SPM

Placebo

Dietary Supplement

Six capsules containing soybean oil daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Official study title

Eicosapentaenoic Acid and Specialized Pro-Resolving Mediator for Depressive Symptoms in Long COVID: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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