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A Clinical Study of Omega-3 on Depression and Cognition

A Clinical Study of Omega-3 on Depression and Cognition

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05941754
Enrollment
64
Registered
2023-07-12
Start date
2022-12-15
Completion date
2024-12-31
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

omega-3, cognition, depression

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.

Interventions

DIETARY_SUPPLEMENTomega-3

supplement in the market

DIETARY_SUPPLEMENTplacebo

corn oil

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
depressive symptom40 minutesHamilton Depression Scale (HAMD)-17, more reduaction mean better outcome

Secondary

MeasureTime frameDescription
Cognitive performance Working memory4 hoursWorking memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)
Cognitive performance Verbal memory4 hoursVerbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.
Cognitive performance Visual memory4 hoursVisual memory: Rey-Osterrieth Complex Figure (ROCF) task
Cognitive performance4 hoursexecutive function: the Stroop Test and the Wisconsin Card Sorting Test (WCST). more improvement mean better outcome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026