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

Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression: a 12 Week Randomized, Double-blind, Placebo-controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Depression; Cognitive Impairment
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin kangguang, PHD,MD; Phone Number: 86-02081268189; Email: klin@connect.hku.hk

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510370
      • Recruiting
      • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
      • Contact: Kangguang Lin, MD，PhD; Phone Number: 13560360144; Email: klin@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjuvant therapy trial group; N-3pufas improved cognitive formula adjuvant therapy intervention group	Dietary supplement: 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
Active Comparator: Adjuvant treatment control group; General fish oil formula product adjuvant treatment control group	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
Placebo Comparator: Placebo assisted treatment control group	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
No Intervention: Healthy group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangzhou Psychiatric Hospital
• Investigators: Principal Investigator: kangguang Lin, PHD,MD, Guangzhou Psychiatric Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: guangzhou brain ω-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No