A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acid as an Augmentor of Antidepressant Medication for Major Depression.
试验速览
- 阶段
- 2 期
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change form pretreatment score on Depression Rating scale at 4 weeks
研究概览
简要总结
The purpose of this study is to determine whether augmentation of antidepressant medication with Omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for patients with major depression
详细描述
The study will be a 4 week, parallel-group double blind randomised control trial of the efficacy pf Omega-3 as an augmentor of antidepressant treatment for depression. People aged between 18 and 65 with a first or new episode of depression warranting treatment with antidepressant medication will be recruited. In addition to their antidepressant medication, participants will be randomly allocated to receive either Omega-3 (fish oil) or placebo (paraffin oil)for 4 weeks. Participants will commence treatment with the antidepressant and Omega-3/placebo simultaneously. Participants will be followed up at 1,3 and 4 weeks and will be asked to rate their mood daily for the 4 week study period. Blood samples will be taken pre and post treatment to measure change in Omega-3 levels.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must present with a first or new episode of DSM IV non-psychotic major depression warranting treatment with antidepressant mediation.
- •Must be able to give informed consent.
排除标准
- •History of psychosis or mania/hypomania or personality disorder.
- •Non-English speaking or otherwise unable to provide historical information.
- •Having taken Omega-3 dietary supplements in the last 3 months.
- •History of allergy to Omega-3 supplements, finfish or shellfish.
- •Pregnancy, breast feeding or plans to become pregnant during course of study.
- •Post-natal depression
- •Current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months.
- •Unstable thyroid function
- •Hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of Omega-3 polyunsaturated fatty acids
- •Coagulopathy or anticoagulant treatment due to theoretical bleeding risk.
- •Patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who will not likely be able to comply with the study protocol.
结局指标
主要结局
Change form pretreatment score on Depression Rating scale at 4 weeks
次要结局
- Daily mood rating
- Weekly measure of depression
- Weekly measure of anxiety
- Weekly measure of functional status