Fish Oil as Adjunct Treatment for Major Depressive Disorder

Study Overview
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Brief Summary
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In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).

Detailed Description
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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.

Official Title
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Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Dietary Supplement: fish oil capsule
* Dietary Supplement: soybean oil capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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. | Dietary Supplement: fish oil capsule<br>* 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.<br>|
| Placebo Comparator: control group<br>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 . | Dietary Supplement: soybean oil capsule<br>* placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hamilton Depression Scale (HAMD) HAMD | Subjects were evaluated for current depression with HAMD. | W0 W4 W12 W24 W48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Clinical Global Impression (CGI) | Subjects were evaluated for current severity of disease with CGI. | W0 W4 W12 W24 W48 | 
| Changes in Hamilton Anxiety Scale (HAMA) | Subjects were evaluated for current anxiety with HAMA. | W0 W4 W12 W24 W48 | 
| Changes in Beck Depression Rating Scale (BDI) | The BDI is a self-report inventory of depression symptom. | W0 W4 W12 W24 W48 | 
| Changes in Self-Rating Anxiety Scale (SAS) | The SAS is a self-report inventory of anxiety symptom. | W0 W4 W12 W24 W48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder,Fish Oil