Fish oil as a depression booster? new trial investigates
NCT ID NCT07645807
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a special fish oil supplement (CreNeuroS) to the antidepressant escitalopram helps reduce depression symptoms more than escitalopram alone. Eighty adults with moderate to severe major depressive disorder will take either the fish oil or a placebo for 8 weeks. Researchers will measure changes in depression scores using the Hamilton Depression Rating Scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CreNeuroS CNS fish oil plus softgels (a dietary supplement) combined with escitalopram (an antidepressant)
- What this could lead to
- If it works, this could point toward a simple, natural supplement to boost the effects of standard antidepressants for people with major depression.
- What could go wrong
- This is a small, early-stage trial with only 80 participants. The fish oil may not provide any additional benefit over the antidepressant alone, and results may not apply to everyone with depression.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female subjects aged between 18 and 65 years, inclusive. 2. Subjects with a clinical diagnosis of Major Depressive Disorder (MDD) as determined by the investigator or qualified psychiatrist, based on standard clinical judgment. 3. Subjects with moderate to severe depression, defined as a Hamilton Depression Rating Scale (HAM-D-17) score ≥18 at both screening and baseline visits. 4. Subjects who are either: * Planned to initiate treatment with escitalopram, or * Have already started escitalopram therapy within ≤2 weeks prior to screening, provided that any prior antidepressant therapy was discontinued with an adequate washout period (≥2 weeks or ≥5 half-lives of the previous medication, whichever is longer) before baseline assessment. 5. Subjects who are medically stable, as assessed by the investigator based on medical history, physical examination, and any relevant laboratory investigations. 6. Subjects who are able and willing to provide written informed consent prior to participation in the study. 7. Subjects who are willing and able to comply with study procedures, treatment regimen, and scheduled study visits. Exclusion Criteria: 1. High suicide risk, defined as: * Presence of active suicidal ideation with intent or plan, or * Subject considered by the investigator to be at significant risk of suicide. * History of suicide attempt or self-harm 2. Presence of major psychiatric disorders other than MDD, including but not limited to: * Bipolar disorder * Schizophrenia or other psychotic disorders 3. Presence of severe or unstable medical conditions that may interfere with study participation or pose a risk to the subject, including but not limited to: * Uncontrolled hepatic (liver) disease * Significant renal (kidney) impairment * Clinically significant cardiovascular disease 4. Known hypersensitivity or allergy to: * Escitalopram * Fish oil or omega-3 fatty acid or folic acid, or L-5-methyltetrahydrofolate supplements 5. Pregnant or lactating women, or women planning to become pregnant during the study period. 6. Use of concomitant medications or treatments that may confound study outcomes, including: * Other antidepressants (unless in the process of being switched to escitalopram) * use of omega-3 or fish oil or folic acid, or L-5-methyltetrahydrofolate supplements 7. Any condition or circumstance which, in the opinion of the investigator, may compromise subject safety, adherence to study procedures, or the integrity of study data. 8. History of substance abuse within 6 months prior to screening. 9. Prior treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the current depressive episode. 10. Initiation of new psychotherapy or change in psychotherapy intensity within 8 weeks prior to screening. 11. Participation in other interventional or non-interventional studies within 3 months prior to screening. 12. High dietary intake of fish (≥3 times per week) or use of fish oil/n-3 PUFA/folate supplements within the past 6 months. 13. Moderate to severe anxiety disorders, as assessed by GAD-7. 14. Participation in another clinical study within 30 days.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jupiter Hospital and Research Centre
Vadodara, Gujarat, 390012, India