Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in Hamilton Depression Scale (HAMD) HAMD
研究概览
简要总结
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
experimental group
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.
干预措施: fish oil capsule (Dietary Supplement)
control group
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 .
干预措施: soybean oil capsule (Dietary Supplement)
结局指标
主要结局
Changes in Hamilton Depression Scale (HAMD) HAMD
时间窗: W0 W4 W12 W24 W48
Subjects were evaluated for current depression with HAMD.
次要结局
- Changes in Clinical Global Impression (CGI)(W0 W4 W12 W24 W48)
- Changes in Hamilton Anxiety Scale (HAMA)(W0 W4 W12 W24 W48)
- Changes in Beck Depression Rating Scale (BDI)(W0 W4 W12 W24 W48)
- Changes in Self-Rating Anxiety Scale (SAS)(W0 W4 W12 W24 W48)
研究者
Jin-Dong Chen
Director of Mental Health Institute of the Second Xiangya Hospital
Second Xiangya Hospital of Central South University