Clinical trial NCT04803071: Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression
Official title: Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression: a 12 Week Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Depression
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-17
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: General information
timeFrame: At baseline
measure: Clinical data
timeFrame: At baseline
measure: Cognitive function assessment
timeFrame: At baseline, at the end of the 4th, 8th and 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
state: Guangdong
Study officials:
affiliation: Guangzhou Psychiatric Hospital
name: kangguang Lin, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References: