Fish Oil as Adjunct Treatment for Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Dietary Supplement: fish oil capsuleDietary Supplement: soybean oil capsule
- Registration Number
- NCT03295708
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group fish oil capsule 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. control group soybean oil capsule 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 .
- Primary Outcome Measures
Name Time Method Changes in Hamilton Depression Scale (HAMD) HAMD W0 W4 W12 W24 W48 Subjects were evaluated for current depression with HAMD.
- Secondary Outcome Measures
Name Time Method Changes in Clinical Global Impression (CGI) W0 W4 W12 W24 W48 Subjects were evaluated for current severity of disease with CGI.
Changes in Hamilton Anxiety Scale (HAMA) W0 W4 W12 W24 W48 Subjects were evaluated for current anxiety with HAMA.
Changes in Beck Depression Rating Scale (BDI) W0 W4 W12 W24 W48 The BDI is a self-report inventory of depression symptom.
Changes in Self-Rating Anxiety Scale (SAS) W0 W4 W12 W24 W48 The SAS is a self-report inventory of anxiety symptom.
Trial Locations
- Locations (1)
Mental Health Institute, Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China