Omega-3 for Delirium

Overseen By Antoinette Burger, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Missouri-Columbia

Must not be taking: Anticoagulants, Omega-3, Omega-6, others

Disqualifiers: Diabetes, Neurodegenerative, Bleeding, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any omega-3, omega-6, vitamin E, or fish oil supplements, as well as any anticoagulant drugs like warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Omega-3 Ethyl Esters for treating delirium?

Research shows that omega-3 fatty acids, like those in Omega-3 Ethyl Esters, have been helpful in reducing symptoms of mental health conditions such as schizophrenia and psychosis, including improvements in depression and anxiety. While this isn't direct evidence for delirium, it suggests potential benefits for brain health and mental clarity. ^{1 2 3 4 5}

Is omega-3 generally safe for humans?

Omega-3 ethyl esters have been studied for various conditions, including heart disease and schizophrenia, and are generally considered safe with no significant side effects reported in these studies. ^{2 4 6 7 8}

How does the drug Omega-3 Ethyl Esters differ from other treatments for delirium?

Omega-3 Ethyl Esters, which include EPA and DHA, are unique because they are derived from fish oil and may help with brain function and inflammation, unlike traditional medications for delirium. While typically used for mood and neuropsychiatric disorders, their role in delirium is still being explored, offering a novel approach compared to standard treatments. ^{7 9 10 11 12}

What is the purpose of this trial?

The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.

Research Team

Quinn Johnson, MD

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

This trial is for individuals aged 65 or older who are undergoing major cardiac surgery and have a physical status classified as I-IV by the American Society of Anesthesiologists. It's not specified, but typically people with certain health conditions that could interfere with the study may be excluded.

Inclusion Criteria

I am 65 years old or older.

My health is classified between ASA I and IV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive omega-3 ethyl esters orally before surgery

1 week

Postoperative Treatment

Participants continue to receive omega-3 ethyl esters for 3 days postoperatively

3 days

Follow-up

Participants are monitored for postoperative delirium and other outcomes until discharge

Up to 30 days

Treatment Details

Interventions

• Omega-3 Ethyl Esters

Trial Overview The study is testing if omega-3 fatty acids at doses of either 4 grams or 2 grams can reduce postoperative delirium when given before and after cardiac bypass surgeries to elderly patients.

Participant Groups

Group I: Omega-3 Ethyl Esters 4 g Experimental Treatment 1 Intervention

Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.

Group II: Omega-3 Ethyl Esters 2 g Experimental Treatment 1 Intervention

Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.

Group III: Standard of Care Active Control 1 Intervention

Patients will not receive any study drug.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Ethyl-eicosapentaenoic acid in first-episode psychosis: a randomized, placebo-controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A placebo-controlled trial of omega-3 fatty acid (ethyl eicosapentaenoic acid) supplementation for residual symptoms and cognitive impairment in schizophrenia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of omega-3 polyunsaturated fatty acids supplements on psychopathology and metabolic parameters in schizophrenia: A meta-analysis of randomized controlled trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled study of ethyl-eicosapentaenoic acid as supplemental treatment in schizophrenia. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A potential role for adjunctive omega-3 polyunsaturated fatty acids for depression and anxiety symptoms in recent onset psychosis: Results from a 16 week randomized placebo-controlled trial for participants concurrently treated with risperidone. [2020]

6. India pubmed.ncbi.nlm.nih.gov

Role of omega-3 fatty acids in the prevention of delirium in mechanically ventilated patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A dose-ranging exploratory study of the effects of ethyl-eicosapentaenoate in patients with persistent schizophrenic symptoms. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Uses and benefits of omega-3 ethyl esters in patients with cardiovascular disease. [2023]

9. France pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids and neuropsychiatric disorders. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Omega-3 Supplementation for Psychotic Mania and Comorbid Anxiety in Children. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Omega-3 in the treatment of violent schizophrenia patients. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Vitamin E and essential polyunsaturated fatty acids supplementation in schizophrenia patients treated with haloperidol. [2017]