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

Guangzhou Psychiatric Hospital

Status: Unknown

Conditions: Cognitive Impairment; Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04803071

guangzhou brain ω-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 4 patient groups, including a placebo group

Adjuvant therapy trial group

Experimental group

Description:

N-3pufas improved cognitive formula adjuvant therapy intervention group

Treatment:

Dietary Supplement: Experimental group of n-pufas improving cognitive formula

Adjuvant treatment control group

Active Comparator group

Description:

General fish oil formula product adjuvant treatment control group

Treatment:

Dietary Supplement: General fish oil formula product adjuvant treatment control group

Placebo assisted treatment control group

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo assisted treatment group

Healthy group

No Intervention group