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

Not Applicable

• Conditions: Cognitive Impairment; Depression
• Interventions: Dietary Supplement: Experimental group of n-pufas improving cognitive formula; Dietary Supplement: General fish oil formula product adjuvant treatment control group; Dietary Supplement: Placebo assisted treatment group

• Registration Number: NCT04803071
• Lead Sponsor: Guangzhou Psychiatric Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

① the patients met the diagnostic criteria of dsm-5 major depressive disorder; ② aged 18-55 years; ③ Hamilton Depression Scale score of 24 items ≥ 20 points; YMRS score < 6 points; ④ 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; ⑤ 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

① Merge with any other mental disorder; ② Patients with history of brain organic disease or traumatic brain injury and physical diseases; ③ abusers of drugs, alcohol or other psychoactive substances; ④ pregnant, lactating women and postpartum women; ⑤ refractory depression; ⑥ severe suicide risk (c-ssrs assessment); ⑦ MECT treatment in recent three months; ③ continuous use of diazepam drugs in recent three months; Ⅸ long-term use of npufas in recent three months; ⑩ Long term use of anti-inflammatory drugs in the past three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant therapy trial group	Experimental group of n-pufas improving cognitive formula	N-3pufas improved cognitive formula adjuvant therapy intervention group
Adjuvant treatment control group	General fish oil formula product adjuvant treatment control group	General fish oil formula product adjuvant treatment control group
Placebo assisted treatment control group	Placebo assisted treatment group	-

Primary Outcome Measures

Name	Time	Method
General information	At baseline	Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
Clinical data	At baseline	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.
Cognitive function assessment	At baseline, at the end of the 4th, 8th and 12th week	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).

Trial Locations

Locations (1)

Guangzhou Brain Hospital (Guangzhou Huiai Hospital); 🇨🇳 Guanzhou, Guangdong, China