NCT05136365已完成2 期
The Efficacy and Safety of Xiongdan Wan on Patients With Major Depressive Disorder : a Single-arm, Non-randomized, Open-label Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study.
研究概览
简要总结
This is a prospective, single-arm, open-label study to evaluate the safety and efficacy of Xiongdan Wan monotherapy in patients with Major Depressive Disorder(MDD), conducted in Shang Hai Mental Health Center. Following a screening period, subjects who meet the entry criteria will be treated with 450mg Xiongdan Wan pills three times daily for 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD): a single or recurrent episode without psychotic features. Codes are as follows: F32.0, F32.1, F32.2, F33.0, F33.1, F33.
- •Outpatients.
- •Male or female subjects aged 18-65 years.
- •HAMD-17 score of the baseline period and screening period is 18-
- •Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.
- •The patient fully understands and signs the informed consent form.
排除标准
- •Patient has survived a suicide attempt or has acute suicidal tendencies (HAMD-17 Item3 ≥3).
- •Comorbidity according to DSM-IV-TR, axis-I except for major depressive disorder.
- •HAMD-17 reduction ratio ≥25% within one week from the screening to the baseline period.
- •Depressive episode secondary to psychiatric illness or somatic disease.
- •Serious and unstable diseases such as cerebrovascular disease; liver and kidney disease; disease of internal secretion (abnormal thyroid function); hemopathy; seizures, or other encephalopathies.
- •History of alcohol or drug abuse over the last 6 months.
- •Allergic history to Xiongdan Wan, or serious drug allergic history.
- •Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months.
- •Clinically significant changes in ECG or laboratory tests, including >1.5 times the upper limit of normal liver function; over the limit of normal renal function and blood sugar; abnormal cardiac troponins; obvious abnormity in the thyroid function.
- •Treatment with modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past three months.
- •Treatment with a systematic psychological treatment in the past three months.
研究组 & 干预措施
Xiongdan Wan group
Experimental
Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder. The daily dose (1350mg per day) should be strictly controlled according to the experimental design.
干预措施: Xiongdan Wan (Drug)
结局指标
主要结局
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study.
时间窗: 8 weeks
The main objective is to explore whether Xiongdan Wan improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at week 1, 2, 4, 8.
次要结局
- Change in the total score of the Hamilton Anxiety Scale(HAMA)(8 weeks)
- The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio(8 weeks)
- Effective treatment(8 weeks)
- Clinical remission rate(8 weeks)
- The Hamilton Depression Rating Scale (HAMD-17) reduction ratio(8 weeks)
- Change in total score of the Clinical Global Impression scale(CGI)(8 weeks)
研究者
LI, Huafang
Executive Director of MICT
Shanghai Mental Health Center
研究点 (1)
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