A Clinical Study of Omega-3 on Depression and Cognition

Not Applicable

• Conditions: Depression
• Interventions: Dietary Supplement: omega-3; Dietary Supplement: placebo

• Registration Number: NCT05941754
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-02-15
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high omega-3 group	omega-3	A single dose of 4.0g EPA was given orally
low omega-3 group	omega-3	A single dose of 2.0g EPA was given orally
placebo group	placebo	A single dose of 4.0g corn oil was given orally

Primary Outcome Measures

Name	Time	Method
depressive symptom	40 minutes	Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome

Secondary Outcome Measures

Name	Time	Method
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
Cognitive performance Verbal memory	4 hours	Verbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.
Cognitive performance Working memory	4 hours	Working memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China