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A Clinical Study of Omega-3 on Depression and Cognition

Primary Purpose

Depression

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
omega-3
placebo
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring omega-3, cognition, depression

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nanfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

No Intervention

Arm Label

high omega-3 group

low omega-3 group

placebo group

healthy control group

Arm Description

A single dose of 4.0g EPA was given orally

A single dose of 2.0g EPA was given orally

A single dose of 4.0g corn oil was given orally

no intervention. assessement of cognitive performance twice.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2023
Last Updated
July 11, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05941754
Brief Title
A Clinical Study of Omega-3 on Depression and Cognition
Official Title
A Clinical Study of Omega-3 on Depression and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
omega-3, cognition, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high omega-3 group
Arm Type
Experimental
Arm Description
A single dose of 4.0g EPA was given orally
Arm Title
low omega-3 group
Arm Type
Experimental
Arm Description
A single dose of 2.0g EPA was given orally
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
A single dose of 4.0g corn oil was given orally
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
no intervention. assessement of cognitive performance twice.
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3
Intervention Description
supplement in the market
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
corn oil
Primary Outcome Measure Information:
Title
depressive symptom
Description
Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Cognitive performance Working memory
Description
Working memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)
Time Frame
4 hours
Title
Cognitive performance Verbal memory
Description
Verbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.
Time Frame
4 hours
Title
Cognitive performance Visual memory
Description
Visual memory: Rey-Osterrieth Complex Figure (ROCF) task
Time Frame
4 hours
Title
Cognitive performance
Description
executive function: the Stroop Test and the Wisconsin Card Sorting Test (WCST). more improvement mean better outcome
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Study of Omega-3 on Depression and Cognition

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