Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Beck depression inventory scale
研究概览
简要总结
Background: Patients with major depressive disorder have prominently been reported to be related with subnormal polyunsaturated omega-3 fatty acids levels, importantly low docosahexaenoic acid and eicosapentaenoic acid in plasma and dietary intake. However, more randomized controlled trials are needed to support its importance in management of depression.
Objective: To explore polyunsaturated omega-3 fatty acid role in major depressive disorder management.
Materials & Methods: Seventy patients 20 to 40 yeas, who were already diagnosed with depression and taking antidepressant treatment, were selected at department of psychiatry and behavioral sciences Kind Edward Medical University Lahore, and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, intervention group advised to take one omega-3 (300mg EPA, eicosapentaenoic acid and 200mg DHA docosahexaenoic acid), or placebo (500 mg corn oil) capsules once daily with meal. Beck Depression Inventory (BDI) scale was used to assess the depression. Demographic information was collected by using a structured questionnaire.
详细描述
Study Design:
12 week Randomized, single blind, placebo-Controlled Trial (RCT) was conducted at King Edward medical university, psychiatry & behavioral sciences department Lahore. From 19 May 2017 to 16 August 2017 one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given (38, 39), or placebo (500 mg corn oil) (40).
Data Collection and Evaluation:
Subjects were assessed at the first visit according to inclusion and exclusion criteria. Information about demographics, dietary habits and risk factors such as age, gender, height, weight and family history of depression, dietary habits, education levels, marital status, cigarette smoking, supplementation and sleeping hours were obtained by using a structured questionnaire in face to face interview in local and easy to understand language. BMI was calculated by using the equation BMI=kg/m2.
Ethical Approval:
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
- Single (Participant)
盲法说明
Along with anti psychotics, one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given to treatment group , and 500 mg corn oil one capsules daily along with anti psychotics were given to placebo group. Patients were unaware about treatment and placebo as plastic transparent same packing was used.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged from 20 to 40 years age and taking anti-depressant drugs, were selected for study.
排除标准
- •Pregnant and lactating women and patients with history of allergy to omega-3 fatty acids shellfish were excluded.
- •Patients with Serious neurological and medical conditions that can likely to interfere with the treatment of depression such as dementia, schizophrenia, epilepsy were also excluded.
结局指标
主要结局
Beck depression inventory scale
时间窗: half an hour
Normal ups down (1-10) Mild mood disturbance (11-16) Borderline clinical depression (17-20) Moderate depression (21-30) Severe depression (31-40) Extreme depression (over 40)
次要结局
未报告次要终点
研究者
Naiza Yousef
Nutritionist
Allama Iqbal Open University Islamabad