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

NCT ID: NCT04803071

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-01

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.

Conditions

Cognitive Impairment; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adjuvant therapy trial group

N-3pufas improved cognitive formula adjuvant therapy intervention group

Group Type: EXPERIMENTAL

Experimental group of n-pufas improving cognitive formula

Intervention Type: DIETARY_SUPPLEMENT

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

Adjuvant treatment control group

General fish oil formula product adjuvant treatment control group

Group Type: ACTIVE_COMPARATOR

General fish oil formula product adjuvant treatment control group

Intervention Type: DIETARY_SUPPLEMENT

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 control group

Group Type: PLACEBO_COMPARATOR

Placebo assisted treatment group

Intervention Type: DIETARY_SUPPLEMENT

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

Healthy group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kangguang Lin

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kangguang Lin, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Psychiatric Hospital

Locations

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Guanzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin kangguang, PHD,MD

Role: CONTACT

klin@connect.hku.hk

86-02081268189

Facility Contacts

Kangguang Lin, MD，PhD

Role: primary

klin@connect.hku.hk

13560360144

Other Identifiers

guangzhou brain ω-3

Identifier Type: -

Identifier Source: org_study_id