COVID - 19, Depression - Major Depressive Disorder
Conditions
Keywords
SPM, EPA, Depression
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTEicosapentaenoic acid (omega-3 fatty acid)
A total daily dose of 3 g, administered as six capsules
DIETARY_SUPPLEMENTSpecialized Pro-Resolving Lipid Mediator
A total daily dose of 1.67 g, administered as six capsules
DIETARY_SUPPLEMENTPlacebo
Six capsules containing soybean oil daily
Sponsors
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
The interventional model, including the supplementation of EPA and SPM
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAMD) | (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
| Measure | Time frame | Description |
|---|---|---|
| Erythrocyte Omega-3 Polyunsaturated Fatty Acids | 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 |
Countries
Taiwan
Outcome results
None listed