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

Last updated: March 15, 2021
Sponsor: Guangzhou Psychiatric Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Memory Problems

Depression

Treatment

N/A

Clinical Study ID

NCT04803071
guangzhou brain ω-3
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:① the patients met the diagnostic criteria of dsm-5 major depressivedisorder; 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) inMCCB tool was less than or equal to its mean half standard deviation; ⑤ antidepressanttypes had not been adjusted in recent 2 weeks; 6) right handedness; 7) primary school hadno change in the types of antidepressants The patients or their family members are willingto participate in the study and sign the informed consent.

Exclusion

Exclusion Criteria:① Merge with any other mental disorder; ② Patients with history of brainorganic 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 inrecent three months; ③ continuous use of diazepam drugs in recent three months; Ⅸ long-termuse of npufas in recent three months; ⑩ Long term use of anti-inflammatory drugs in thepast three months.

Study Design

Total Participants: 288
Study Start date:
October 01, 2020
Estimated Completion Date:
October 01, 2022

Study 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.

Connect with a study center

  • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

    Guanzhou, Guangdong 510370
    China

    Active - Recruiting

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