Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)
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 people with subthreshold depression.The purpose of this clinical trial is to investigate the efficacy of LBP in people with subthreshold depression.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15-25 scores in the Beck Depression Rating Scale (BDI- II)
- •There is no contraindication of taking LBP.
排除标准
- •Current treatment for a mental health problem from a mental health professional
- •Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
- •Systemic disease requiring regular medication.
- •There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
- •Dislike of or allergy to goji berry
- •Hormone or Endocrine therapeutic drugs are being taken.
- •Long-term use of lycium chinensis in recent three months
结局指标
主要结局
Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)
时间窗: 6 weeks
The 24-item HAM-D scale is widely used to assess the severity of depression.The scale is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed).
次要结局
- Depression severity as measured by BDI2 and Kessler Scale (K10)(6 weeks)
- Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores(6 week)
- Changes in The Screen for Child Anxiety Related Disorders (SCARED)(4 and 6 weeks)
- Changes in sleep quality(6 weeks)
研究者
Kangguang Lin
Deputy director, Department of Affective disorders
Guangzhou Psychiatric Hospital