Back to resultsOmega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression
Primary Purpose
Cognitive Impairment, Depression
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental group of n-pufas improving cognitive formula
General fish oil formula product adjuvant treatment control group
Placebo assisted treatment group
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment
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.
Sites / Locations
- Guangzhou Brain Hospital (Guangzhou Huiai Hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Adjuvant therapy trial group
Adjuvant treatment control group
Placebo assisted treatment control group
Healthy group
Arm Description
N-3pufas improved cognitive formula adjuvant therapy intervention group
General fish oil formula product adjuvant treatment control group
Outcomes
Primary Outcome Measures
General information
Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04803071
First Posted
March 15, 2021
Last Updated
March 15, 2021
Sponsor
Guangzhou Psychiatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04803071
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adjuvant therapy trial group
Arm Type
Experimental
Arm Description
N-3pufas improved cognitive formula adjuvant therapy intervention group
Arm Title
Adjuvant treatment control group
Arm Type
Active Comparator
Arm Description
General fish oil formula product adjuvant treatment control group
Arm Title
Placebo assisted treatment control group
Arm Type
Placebo Comparator
Arm Title
Healthy group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental group of n-pufas improving cognitive formula
Intervention Description
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
Intervention Name(s)
General fish oil formula product adjuvant treatment control group
Intervention Description
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
Intervention Name(s)
Placebo assisted treatment group
Intervention Description
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
Primary Outcome Measure Information:
Title
General information
Description
Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
Time Frame
At baseline
Title
Clinical data
Description
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.
Time Frame
At baseline
Title
Cognitive function assessment
Description
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).
Time Frame
At baseline, at the end of the 4th, 8th and 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin kangguang, PHD,MD
Phone
86-02081268189
Email
klin@connect.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kangguang Lin, PHD,MD
Organizational Affiliation
Guangzhou Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD，PhD
Phone
13560360144
Email
klin@connect.hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression
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