Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Reduction rate of Hamilton Depression Scale (HDRS)
研究概览
简要总结
Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia. Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years old
- •Sex: both men and women
- •Compliance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for major depressive disorder
- •Hamilton Depression Scale scored more than 18 points.
- •No contraindication of taking Lycium barbarum polysaccharide
排除标准
- •Comorbidity with other mental disorders
- •Severe somatic diseases
- •Current use of traditional Chinese medicine
- •Suicide concept, attempt, act and attempted suicide
- •Psychiatric symptoms
- •Taking hormones and endocrine drugs
- •Long-term use of wolfberry in recent three months
结局指标
主要结局
Reduction rate of Hamilton Depression Scale (HDRS)
时间窗: 4weeks, 6weeks
HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points. Clinical control, HDRS score reduction rate≥75%; significant progress, 50%≤HDRS score reduction rate \< 75%; progress, 25%≤HDRS score reduction rate \< 50%; ineffectiveness, HDRS score reduction rate \< 25%. significant efficiency = (clinical control + significant progress) / sample number×100%.
次要结局
- Changes in serum brain-derived neurotrophic factor (BDNF) levels(6 weeks)
- Changes in sleep quality(4 weeks, 6 weeks)
- Changes in cognitive function(4 weeks, 6 weeks)
- Changes in social adaptive levels(4 weeks, 6 weeks)
- Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)(4 weeks, 6 weeks)
- Changes in serum triglyceride levels(6 weeks)
- Changes in serum total cholesterol levels(6 weeks)
研究者
Kangguang Lin
Deputy director, Department of Affective Disorder
Guangzhou Psychiatric Hospital