A Clinical Study of Omega-3 on Depression and Cognition

Sponsor

Nanfang Hospital, Southern Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05941754

Collaborator

(none)

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Previous studies on the antidepressant effects of Omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. Because of the nature of Omega-3 health products, no clinical adverse effects have been reported. We have previously shown that Omega-3 can produce antidepressant and cognitive improvement effects. This study will carry out different doses (low dose and high dose) and single active ingredient (EPA alone) to observe the antidepressant and cognitive improvement effects of Omega-3 in clinical patients with major depression. The antidepressant effect and cognitive improvement effect of Omega-3 will be further verified to provide evidence for future clinical application.

Condition or Disease	Intervention/Treatment	Phase
Depression	Dietary Supplement: omega-3 Dietary Supplement: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Clinical Study of Omega-3 on Depression and Cognition

Actual Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high omega-3 group A single dose of 4.0g EPA was given orally	Dietary Supplement: omega-3 supplement in the market
Experimental: low omega-3 group A single dose of 2.0g EPA was given orally	Dietary Supplement: omega-3 supplement in the market
Placebo Comparator: placebo group A single dose of 4.0g corn oil was given orally	Dietary Supplement: placebo corn oil
No Intervention: healthy control group no intervention. assessement of cognitive performance twice.

Outcome Measures

Primary Outcome Measures

depressive symptom [40 minutes]
Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome

Secondary Outcome Measures

Cognitive performance Working memory [4 hours]
Working memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)
Cognitive performance Verbal memory [4 hours]
Verbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.
Cognitive performance Visual memory [4 hours]
Visual memory: Rey-Osterrieth Complex Figure (ROCF) task
Cognitive performance [4 hours]
executive function: the Stroop Test and the Wisconsin Card Sorting Test (WCST). more improvement mean better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

current moderate to severe depressive episode (DSM-5)
HAMD-17>16
18≤Age≤45
Never use of fluoxetine and no use of any antipsychotic and antidepressant drugs and mood stablizer at least 8 weeks
Current physical or laboratory tests show good health
negative usrine drug tests
voluntray to sign the consent form

Exclusion Criteria:

treat-resistant depressive disorder
other axis I/II dignoses
MMSE≤27 recent abuse history of alcohol or drugs pregnant or breast breeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital	Guangzhou	Guangdong	China

Sponsors and Collaborators

Nanfang Hospital, Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital, Southern Medical University

ClinicalTrials.gov Identifier:

NCT05941754

Other Study ID Numbers:

NFEC-2023-051

First Posted:

Jul 12, 2023

Last Update Posted:

Jul 12, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Nanfang Hospital, Southern Medical University

omega-3

cognition

depression

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Jul 12, 2023