Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication.
Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.
详细描述
Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication.
This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of relapsing-remitting MS
- •Diagnosis of depressive disorder
- •Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- •Score of 25 or greater on the Mini-Mental State Examination (MMSE)
- •Currently taking antidepressant medication for at least 3 months prior to study entry
排除标准
- •Currently taking fatty acid supplements
- •Consume more than 6 oz of fish per week within 1 month prior to study entry
- •Severe depression
- •Suicidal thoughts
- •Other psychological disorders
- •Currently taking more than two types of antidepressants
- •Any serious medical condition that would interfere with the study
- •Worsening of MS symptoms or corticosteroid treatment within 1 month prior to study entry
- •Current enrollment in another fish oil study
- •Pregnancy
研究组 & 干预措施
Fish oil concentrate
Fish oil concentrate
干预措施: Fish oil concentrate (Drug)
Placebo oil
Placebo oil
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: baseline to 3 months
Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and \> 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).
次要结局
- Quality of Life (SF-36)(baseline to 3 months)
研究者
Lynne Shinto
Lynn Shinto, ND, MPH
Oregon Health and Science University