Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression

Depression Clinical Trial

Official title:

Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression: a 12 Week Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803071
• Other study ID #: guangzhou brain ?-3
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2021
• Source: Guangzhou Psychiatric Hospital
• Contact: Lin kangguang, PHD,MD
• Phone: 86-02081268189
• Email: klin[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression

Description:

Depression is often accompanied by cognitive impairment. At present, there is no effective drug to improve the cognitive impairment in patients with depression, and the social function and quality of life of patients are affected in varying degrees. N-3 polyunsaturated fatty acids (n-3pufas) are food products with high safety and few adverse reactions. Previous clinical trials have also suggested that n-3pufas may help to improve cognitive impairment in patients with depression, but the reported results are different. We have developed a new generation of n-3pufas optimal proportion combination products and found good cognitive improvement effect in animal models of depression. Therefore, this clinical research project will screen out the depressive patients with cognitive impairment through the cognitive function battery test (MCCB) tool for schizophrenia. On the basis of routine treatment of depression, these patients will be added with the cognitive improvement formula n-3pufas capsule developed by us to explore the effect of n-3pufas formula on cognitive impairment of depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:? the patients met the diagnostic criteria of dsm-5 major depressive disorder; ? aged 18-55 years; ? Hamilton Depression Scale score of 24 items = 20 points; YMRS score < 6 points; ? the score of wms-ii spatial span (assessment of working memory) in MCCB tool was less than or equal to its mean half standard deviation; ? antidepressant types had not been adjusted in recent 2 weeks; 6) right handedness; 7) primary school had no change in the types of antidepressants The patients or their family members are willing to participate in the study and sign the informed consent.

Exclusion Criteria:? Merge with any other mental disorder; ? Patients with history of brain organic disease or traumatic brain injury and physical diseases; ? abusers of drugs, alcohol or other psychoactive substances; ? pregnant, lactating women and postpartum women; ? refractory depression; ? severe suicide risk (c-ssrs assessment); ? MECT treatment in recent three months; ? continuous use of diazepam drugs in recent three months; ? long-term use of npufas in recent three months; ? Long term use of anti-inflammatory drugs in the past three months.

Related Conditions & MeSH terms

• Cognitive Impairment
• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Experimental group of n-pufas improving cognitive formula
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
• General fish oil formula product adjuvant treatment control group
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
• Placebo assisted treatment group
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

Locations

Country	Name	City	State
China	Guangzhou Brain Hospital (Guangzhou Huiai Hospital)	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General information	Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.	At baseline
Primary	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
Primary	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