NCT02191384已完成2 期
Proof Of Concept Study of Orcinoside in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical 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
- 186
- 试验地点
- 10
- 主要终点
- The change of total score from baseline in MADRS and HAMD scale
研究概览
简要总结
The purpose of this study is to determine whether Orcinoside Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in the Chinese Patients with 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult with primary diagnosis of major depressive disorder based on the criteria of DSM-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included:
- •296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent episode, mild 296.32 MDD recurrent episode, moderate
- •The subject is an outpatient.
- •The subject is a man or woman,aged≥18 and ≤65 years.
- •The total score of HAMD-17 is ≥18 and ≤24 in both screening visit and baseline visit.
- •The subject is willing to take birth control measures during study period and one month after study.
- •The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent.
排除标准
- •The subject has a significant risk of suicide according to the investigator's opinion or has a score ≥3 on item 3(suicide assessment) of the HAMD or has made a suicide attempt.
- •The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
- •When the HAMD17 score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- •The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition, bipolar disorder, or depression accompanied with psychotic symptoms.
- •Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood,or other medical disease. Had a history of seizure disorder or other brain organic disorders.
- •The subject has a diagnosis of alcohol or other substance abuse or dependence at least 1 years prior to the baseline visit.
- •Known hypersensitivity to Common Curculigo Rhizome or other drugs.
- •Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility within half of year.
- •Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function above toplimit, blood glucose above toplimit, cardiac troponin abnormal, thyroid gland examine index significantly abnormal).
- •The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug less than 7 half-life period (monoamine oxidase inhibitor more than 2 weeks, fluoxetine more than 1 month).
- •The subject has accepted electroconvulsive therapy within 3months.
- •The subject has accepted system psychotherapy within 3 months.
- •The compliance of the subject is poor.
- •The subject has participated in a drug clinical trial within 30 days before screening.
- •The investigator think the subject is unsuitable to enrol in this clinical trial.
研究组 & 干预措施
Orcinoside 400mg per day
Experimental
干预措施: Orcinoside (Drug)
Orcinoside 600mg per day
Experimental
干预措施: Orcinoside (Drug)
Orcinoside 100mg per day
Experimental
干预措施: Orcinoside (Drug)
Orcinoside 200mg per day
Experimental
干预措施: Orcinoside (Drug)
Orcinoside 25mg per day
Experimental
干预措施: Orcinoside (Drug)
Orcinoside 50mg per day
Experimental
干预措施: Orcinoside (Drug)
placebo
Placebo Comparator
干预措施: Orcinoside (Drug)
结局指标
主要结局
The change of total score from baseline in MADRS and HAMD scale
时间窗: 6 weeks
次要结局
- sleep VAS scale.(6 weeks)
- response rate and remission rate(6 weeks)
- decreasing rate from baseline in MADRS(6 weeks)
- decreasing rate from baseline in HAMD scale(6 weeks)
- change from baseline in HAMA(6 weeks)
- CGI(CGI-S,CGI-I)(6 weeks)
研究者
LI, Huafang
Executive Director of MICT
Shanghai Mental Health Center
研究点 (10)
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