A Clinical Study of Omega-3 on Depression and Cognition

NCT05941754 | Unknown DMC

• 1 other identifier: NFEC-2023-051
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

omega-3; cognition; depression

Outcome Measures

Primary Outcomes (1)

• depressive symptom

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

  40 minutes

Secondary Outcomes (4)

• Cognitive performance Working memory

  4 hours

• Cognitive performance Verbal memory

  4 hours

• Cognitive performance Visual memory

  4 hours

• Cognitive performance

  4 hours

Study Arms (4)

high omega-3 group

EXPERIMENTAL

A single dose of 4.0g EPA was given orally

Dietary Supplement: omega-3

low omega-3 group

EXPERIMENTAL

A single dose of 2.0g EPA was given orally

Dietary Supplement: omega-3

placebo group

PLACEBO COMPARATOR

A single dose of 4.0g corn oil was given orally

Dietary Supplement: placebo

healthy control group

NO INTERVENTION

no intervention. assessement of cognitive performance twice.

Interventions

omega-3 DIETARY_SUPPLEMENT

supplement in the market

high omega-3 group; low omega-3 group

placebo DIETARY_SUPPLEMENT

corn oil

placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• current moderate to severe depressive episode (DSM-5)
• HAMD-17\>16
• ≤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

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Depression

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: July 12, 2023
• Study Start: December 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)