The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Depression Residual Symptom Scale
研究概览
简要总结
The purpose of this study is to determine whether Korean Red Ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.
详细描述
Thirty-five female outpatients aging from 18 to 65 years, who were remitted from major depression with residual symptoms (Montgomery Asberg Depression Rating Scale, MADRS ≤ 12), were given Korean red ginseng at doses of 3g / day during 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
- •Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval.
- •Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms.
排除标准
- •Those who have a history of substance abuse or dependence within 1 month.
- •Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
- •Those who have a past history of hypersensitivity or intolerance to Korean red ginseng.
- •Those who participated in clinical trials within 1 month before entering the study entry.
- •Those who are pregnant or are breast feeding.
- •Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
- •The patients unable/unlikely to comprehend/follow the protocol.
结局指标
主要结局
Depression Residual Symptom Scale
时间窗: 8 weeks
This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).
次要结局
- Visual Analogue Scale(8 weeks)
- Montgomery Asberg Depression Rating Scale(8 weeks)
- Clinical Global Index(8 weeks)
研究者
Young-Hoon Ko
Associate Professor
Korea University