A Clinical Study of Omega-3 on Depression and Cognition

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study of Omega-3 on Depression and Cognition

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: omega-3
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depressive symptom | Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome | 40 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3, cognition, depression