Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression
1 other identifier
interventional
288
1 country
1
Brief Summary
The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 17, 2021
March 1, 2021
2 years
March 15, 2021
March 15, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
General information
Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
At baseline
Clinical data
Including the age of the first onset, the total course of disease, the course of the disease, the number of attacks, past medical history, family history, suicide and self injury.
At baseline
Cognitive function assessment
Six cognitive dimensions, including processing speed, attention, working memory, language learning and memory, visual learning and memory, and executive function, were assessed by using standardized set of computer cognitive test (MCCB) based on MCCB, together with TONI-3 and tower of London (tower of London).
At baseline, at the end of the 4th, 8th and 12th week
Study Arms (4)
Adjuvant therapy trial group
EXPERIMENTALN-3pufas improved cognitive formula adjuvant therapy intervention group
Adjuvant treatment control group
ACTIVE COMPARATORGeneral fish oil formula product adjuvant treatment control group
Placebo assisted treatment control group
PLACEBO COMPARATORHealthy group
NO INTERVENTIONInterventions
Three times a day, one capsule of n-3pufas improvement cognitive formula capsule (once in the morning, in the evening) and routine treatment for depression, lasting for 12 weeks
The control group: 1 capsule of general fish oil formula (once in the morning, in the evening) three times a day, plus routine treatment for depression, lasting for 12 weeks
Three times a day, one capsule of placebo adjuvant therapy (once in the morning, one in the evening) and conventional treatment of depression for 12 weeks
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Guanzhou, Guangdong, 510370, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
kangguang Lin, PHD,MD
Guangzhou Psychiatric Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 17, 2021
Study Start
October 1, 2020
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
March 17, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share