A Randomized, Parallel-group，Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Ethosuximide in Chinese Patients With Treatment-Resistant Depression.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Montgomery and Asberg Depression Rating Scale(MADRS） score
研究概览
简要总结
This study evaluates the efficacy and safety of ethosuximide in the treatment of refractory depressive disorder in adults. Half of participants will receive ethosuximide and escitalopram in combination, while the other half will receive a placebo and escitalopram.
详细描述
Ethosuximide is a inhibitor of low-voltage-sensitive T-type calcium channels(T-VSCCs). It has higher selectivity to T-VSCCs and can enter cerebrospinal fluid through the blood-brain barrier, inhibit T-VSCCs on the lateral habenular nucleus neurons, and then inhibit the cluster discharge of neurons, resulting in a rapid antidepressant effect.
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)
盲法说明
This study is a double-blind and double-simulation design. In the course of clinical study, all subjects, researchers and evaluators are blind to grouping information. The results of the study are audited by blind state data. The placebos are administered in capsules with no difference in appearance, color, weight or odor from the positive drugs. Both subjects and drugs are coded blindly.
In the study, the coding system for research drugs have an emergency blindness detection procedure, so as to quickly identify the drugs in emergency medical condition, without destroying the blind design of clinical research.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group
Ethosuximide(2 weeks) + Escitalopram (4 weeks)
干预措施: Ethosuximide (Drug)
Experimental group
Ethosuximide(2 weeks) + Escitalopram (4 weeks)
干预措施: Escitalopram (Drug)
Control group
Placebo(2 weeks)+Escitalopram(4 weeks)
干预措施: Placebo (Drug)
Control group
Placebo(2 weeks)+Escitalopram(4 weeks)
干预措施: Escitalopram (Drug)
结局指标
主要结局
Montgomery and Asberg Depression Rating Scale(MADRS） score
时间窗: baseline and 43 days
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, \>34 - severe depression. Changes of MADRS score at therapeutic visit point compare with baseline.
次要结局
- MADRS score(baseline and 43 days)
- Remission rate after 2 and 4 weeks of treatment.(baseline, week 2 and week 4)
- Young manic rating scale(YMRS） score(baseline and 43 days)
- Hamilton Anxiety Rating Scale(HAMA） score(baseline and 43 days)
- Quick Inventory of Depressive Symptomatology-Self Report(QIDS-SR） score(baseline and 43 days)
- Efficiency after 2 and 4 weeks of treatment.(baseline, week 2 and week 4)
研究者
Xu Yi
Doctor of Medicine
Zhejiang University