A Clinical Study of Omega-3 on Depression and Cognition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- depressive symptom
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
- •treat-resistant depressive disorder
- •other axis I/II dignoses
- •MMSE≤27 recent abuse history of alcohol or drugs pregnant or breast breeding
Arms & Interventions
high omega-3 group
A single dose of 4.0g EPA was given orally
Intervention: omega-3 (Dietary Supplement)
placebo group
A single dose of 4.0g corn oil was given orally
Intervention: placebo (Dietary Supplement)
healthy control group
no intervention. assessement of cognitive performance twice.
low omega-3 group
A single dose of 2.0g EPA was given orally
Intervention: omega-3 (Dietary Supplement)
Outcomes
Primary Outcomes
depressive symptom
Time Frame: 40 minutes
Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome
Secondary Outcomes
- Cognitive performance Visual memory(4 hours)
- Cognitive performance(4 hours)
- Cognitive performance Verbal memory(4 hours)
- Cognitive performance Working memory(4 hours)