Back to resultsFish Oil as Adjunct Treatment for Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fish oil capsule
soybean oil capsule
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder,Fish Oil
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- Men or women aged 18-50 years
- A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
- HAMD total score≥21
- No significantly modification of their diet from the time they sign consent to the end of study participation
Exclusion Criteria:
- Suffering from other serious somatic diseases or comorbidities
- Patients with serious nervous system disease
- Patients in accordance with diagnostic standards of other mental illness
- Patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months
- Pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures
- Patients with apparent suicide attempt or suicidal behavior
- Any condition or medicines that may have an effect on biomarkers (within 1 week of the screening period or during whole trial period): long-term, regular use of NSAIDs, COX-2 inhibitors, immunosuppressant, steroids, interferon, chemotherapeutics, anticoagulants, malignancy, active autoimmune diseases, inflammatory bowel diseases, etc
- Allergy history of PUFA
- Intake of Fish oil more than 3g per day or eat fatty fish more than 3 times a week
Sites / Locations
- Mental Health Institute, Second Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
the experimental group will be given 4 fish oil capsules (1g/one capsule)twice daily after two meals at roughly the same time each day,lasting for the first 6 months.fish oil capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.
the control group will be given 4 soybean oil capsules ( placebo capsule,1g/one capsule) twice daily after two meals at roughly the same time each day,lasting for the first 6 months.placebo capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.The placebo capsule's appearance and flavor are made the exactly the same as the fish oil capsules .
Outcomes
Primary Outcome Measures
Changes in Hamilton Depression Scale (HAMD) HAMD
Subjects were evaluated for current depression with HAMD.
Secondary Outcome Measures
Changes in Clinical Global Impression (CGI)
Subjects were evaluated for current severity of disease with CGI.
Changes in Hamilton Anxiety Scale (HAMA)
Subjects were evaluated for current anxiety with HAMA.
Changes in Beck Depression Rating Scale (BDI)
The BDI is a self-report inventory of depression symptom.
Changes in Self-Rating Anxiety Scale (SAS)
The SAS is a self-report inventory of anxiety symptom.
Full Information
NCT ID
NCT03295708
First Posted
September 18, 2017
Last Updated
October 6, 2017
Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03295708
Brief Title
Fish Oil as Adjunct Treatment for Major Depressive Disorder
Official Title
Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Xiangya Hospital of Central South University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).
Detailed Description
Participants are randomly assigned to two groups (n=60): control (placebo, soybean) and fish oil (containing EPA 1440mg, DHA 960mg). The experimental groups will be compared to placebo to evaluate if it may benefit clinical symptoms, cognitive symptoms and metabolic markers in MDD patients. We also plan to investigate the changes in markers of inflammation at the same time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder,Fish Oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
the experimental group will be given 4 fish oil capsules (1g/one capsule)twice daily after two meals at roughly the same time each day,lasting for the first 6 months.fish oil capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
the control group will be given 4 soybean oil capsules ( placebo capsule,1g/one capsule) twice daily after two meals at roughly the same time each day,lasting for the first 6 months.placebo capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.The placebo capsule's appearance and flavor are made the exactly the same as the fish oil capsules .
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil capsule
Intervention Description
N-3 PUFAs is a kind of essential fatty acid,however the formation is too slow. Studies show that intakes of N-3 PUFAs is associated with MDD.It have to be got from food like deep-sea fishes. EPA and DHA are crucial for the body.Although studies have shown that reduced N-3 PUFAs were correlated with MDD, and patients with an elevated rate of N-6 PUFAs /N-3 PUFAs or a low level of DHA may be at higher odds for suicide. Trials on whether N-3 PUFAs is effective in the treatment of MDD is still controversial, which might be affected by several factors, such as dose, duration etc.. Now there is no large-scale randomized controlled clinical trial in determining the effects of N-3 PUFAs add-on in treatment of MDD.
Intervention Type
Dietary Supplement
Intervention Name(s)
soybean oil capsule
Intervention Description
placebo capsule
Primary Outcome Measure Information:
Title
Changes in Hamilton Depression Scale (HAMD) HAMD
Description
Subjects were evaluated for current depression with HAMD.
Time Frame
W0 W4 W12 W24 W48
Secondary Outcome Measure Information:
Title
Changes in Clinical Global Impression (CGI)
Description
Subjects were evaluated for current severity of disease with CGI.
Time Frame
W0 W4 W12 W24 W48
Title
Changes in Hamilton Anxiety Scale (HAMA)
Description
Subjects were evaluated for current anxiety with HAMA.
Time Frame
W0 W4 W12 W24 W48
Title
Changes in Beck Depression Rating Scale (BDI)
Description
The BDI is a self-report inventory of depression symptom.
Time Frame
W0 W4 W12 W24 W48
Title
Changes in Self-Rating Anxiety Scale (SAS)
Description
The SAS is a self-report inventory of anxiety symptom.
Time Frame
W0 W4 W12 W24 W48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent
Men or women aged 18-50 years
A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
HAMD total score≥21
No significantly modification of their diet from the time they sign consent to the end of study participation
Exclusion Criteria:
Suffering from other serious somatic diseases or comorbidities
Patients with serious nervous system disease
Patients in accordance with diagnostic standards of other mental illness
Patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months
Pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures
Patients with apparent suicide attempt or suicidal behavior
Any condition or medicines that may have an effect on biomarkers (within 1 week of the screening period or during whole trial period): long-term, regular use of NSAIDs, COX-2 inhibitors, immunosuppressant, steroids, interferon, chemotherapeutics, anticoagulants, malignancy, active autoimmune diseases, inflammatory bowel diseases, etc
Allergy history of PUFA
Intake of Fish oil more than 3g per day or eat fatty fish more than 3 times a week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Wang, MD
Phone
+8615116331768
Email
luwang112@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mimi Tang, MD
Phone
+8615802607545
Email
tangmimi1989@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jindong Chen, MD
Organizational Affiliation
Central South University
Official's Role
Study Director
Facility Information:
Facility Name
Mental Health Institute, Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang, M.D.
Phone
+8615116331768
Email
luwang112@163.com
First Name & Middle Initial & Last Name & Degree
Mi Mi Tang, M.D.
Phone
+8617136372000
Email
tangmimi1989@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
June 1,2020, Email to Dr. Chen Jindong(chenjd269@163.com)
Citations:
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19531277
Citation
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Fish Oil as Adjunct Treatment for Major Depressive Disorder
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