CClinicalTrials.gg
Enrolling by invitationNCT05941754Updated Jul 12, 2023

A Clinical Study of Omega-3 on Depression and Cognition

An interventional study of omega-3 and placebo in Depression, sponsored by Nanfang Hospital, Southern Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depression

Keywords

  • omega-3
  • cognition
  • depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 64 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

Exclusion Criteria:

  • treat-resistant depressive disorder
  • other axis I/II dignoses
  • MMSE≤27 recent abuse history of alcohol or drugs pregnant or breast breeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    high omega-3 group

    A single dose of 4.0g EPA was given orally

    Dietary Supplement: omega-3

  • Experimental
    low omega-3 group

    A single dose of 2.0g EPA was given orally

    Dietary Supplement: omega-3

  • Placebo comparator
    placebo group

    A single dose of 4.0g corn oil was given orally

    Dietary Supplement: placebo

  • No intervention
    healthy control group

    no intervention. assessement of cognitive performance twice.

Interventions

  • Dietary supplementomega-3

    supplement in the market

  • Dietary supplementplacebo

    corn oil

06

What researchers measure

Primary outcomes

  1. depressive symptom

    Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome

    Time frame: 40 minutes

Secondary outcomes

  1. Cognitive performance Working memory

    Working memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)

    Time frame: 4 hours

  2. Cognitive performance Verbal memory

    Verbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.

    Time frame: 4 hours

  3. Cognitive performance Visual memory

    Visual memory: Rey-Osterrieth Complex Figure (ROCF) task

    Time frame: 4 hours

  4. Cognitive performance

    executive function: the Stroop Test and the Wisconsin Card Sorting Test (WCST). more improvement mean better outcome

    Time frame: 4 hours

07

Study locations

1 site
  • Nanfang Hospital
    Guangzhou, Guangdong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05941754
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Dec 15, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion