A Clinical Study of Omega-3 on Depression and Cognition

Depression Clinical Trial

Official title:

A Clinical Study of Omega-3 on Depression and Cognition

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05941754
• Other study ID #: NFEC-2023-051
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• omega-3
supplement in the market
• placebo
corn oil

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depressive symptom	Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome	40 minutes
Secondary	Cognitive performance Working memory	Working memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)	4 hours
Secondary	Cognitive performance Verbal memory	Verbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.	4 hours
Secondary	Cognitive performance Visual memory	Visual memory: Rey-Osterrieth Complex Figure (ROCF) task	4 hours
Secondary	Cognitive performance	executive function: the Stroop Test and the Wisconsin Card Sorting Test (WCST). more improvement mean better outcome	4 hours