Summary
Omega-3 fatty acids (EPA/DHA) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Major Depressive Disorder. ClinicalTrials.gov lists 8 registered trials linking Omega-3 fatty acids (EPA/DHA) to Major Depressive Disorder: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 3 (NCT00517036). The largest enrolment is 230 participants (NCT01620502). Registration activity spans 2004 to 2025. No published literature item is linked to Omega-3 fatty acids (EPA/DHA) and Major Depressive Disorder in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Major Depressive Disorder ranks 580 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Relapse in 19-45% within 1 year of antidepressant discontinuation after remission; relapse risk ratio (off-medication vs on) falls from 3.69x at 2 months to 1.34x at 5 years.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 31.0 (trials 26.0, literature 0.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 0 |
| Agent type | Supplement |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Integrative interventions for improving outcomes in depression: a narrative review · Halma M, Plothe C, Marik PE · 2024 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00517036 | Omega-3 Fatty Acids for Treating Adults With Major Depression 2006 | completed | Phase 3 | 196 |
| NCT00361374 | Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression 2006 | completed | Phase 3 | 196 |
| NCT05774665 | Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression 2025 | active, not recruiting | Phase 2 | 14 |
| NCT00816322 | The Effect of Fish Oil in Major Depressive Disorder 2005 | completed | Not applicable | 120 |
| NCT00618865 | Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy 2004 | completed | Not applicable | 36 |
| NCT01620502 | N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression 2009 | completed | Not applicable | 230 |
| NCT03072823 | Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases 2016 | completed | Not applicable | 60 |
| NCT05899660 | Impact of Omega 3 in Alcohol Use Disorder 2023 | recruiting | Not applicable | 100 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: Integrative interventions for improving outcomes in depression: a narrative review · Halma M, Plothe C, Marik PE · 2024.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Omega-3 fatty acids (EPA/DHA) approved for Major Depressive Disorder?
Omega-3 fatty acids (EPA/DHA) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Major Depressive Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Omega-3 fatty acids (EPA/DHA) in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Omega-3 fatty acids (EPA/DHA) to Major Depressive Disorder: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 3 (NCT00517036). The largest enrolment is 230 participants (NCT01620502). Registration activity spans 2004 to 2025.
What does the evidence show for Omega-3 fatty acids (EPA/DHA) in Major Depressive Disorder?
Omega-3 fatty acids (EPA/DHA) has 6 completed registered trials for Major Depressive Disorder but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.