Clinical Study of Flupentixol and Melitracen Tablets in the Treatment of Non Random Emotional Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effectiveness of Flupentixol and Melitracen Tablets
研究概览
简要总结
To evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders
详细描述
Involuntary emotional expression disorder (ieed) is a kind of disorder of emotion control. Its main clinical feature is frequent short and violent uncontrollable crying and (or) laughing, which is different from mood disorder and self emotional expression.
The mixture of Flupentixol and melitracen is used for antidepressant. Melitracen is a tricyclic antidepressant, while Flupentixol is a neurodepressant in structure, but its dose in Deanxit has antidepressant properties.
The active components of Deanxit are Flupentixol dihydrochloride (Flupentixol) and melitracen (melitracen). Flupentixol is a thiazolyl (thioanthracene) antipsychotic, and melitracen is a tricyclic antidepressant. Low dose Flupentixol (0.5mg-3mg) has antidepressant and antianxiety effects, while melitracen has antidepressant effect. The mixture of the two components is used to treat mild to moderate mental disorders.
The purpose of this study was to evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged 18-70;
- •Patients with nervous system diseases (such as stroke, amyotrophic lateral sclerosis, brain trauma, multiple sclerosis, Alzheimer's disease, etc.) accompanied by non random emotional expression disorder;
- •The informed consent form signed by the subject indicates that the subject has been informed of all the contents related to the study;
- •The subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory examination and other study procedures.
排除标准
- •patients with acute infection, acute trauma, perioperative period and acute attack of chronic diseases;
- •Patients in critical condition or dying can not participate in this study;
- •Pregnant or lactating women;
- •Substance abuse patients;
- •Allergic to Deanxit;
- •Mental disorder; Coma;
- •Untreated angle closure glaucoma;
- •In the early recovery of myocardial infarction, patients with different degrees of heart block or arrhythmia and coronary artery ischemia;
- •Monoamine oxidase inhibitors were used;
- •Participated in any other studies involving studies or post marketing drugs within 30 days prior to screening;
- •According to the judgment of the researcher, there are other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risks associated with participating in the trial or using the research products, or may affect the interpretation of the research results, which may make the subjects unsuitable for participating in the trial;
- •Inability and / or unwillingness to understand and / or comply with the protocol.
研究组 & 干预措施
Flupentixol melitracen tablets
The patients were treated with Flupentixol melitracen tablets according to their own conditions
干预措施: Flupentixol melitracen tablets (Drug)
结局指标
主要结局
Effectiveness of Flupentixol and Melitracen Tablets
时间窗: The change of frequence of forced crying betwen baseline and twelfth week.
Indicators of drug effectiveness: the difference between the number of crying episodes after 12 weeks of medication minus the number of crying episodes at baseline divided by the number of crying episodes at baseline. Complete remission was achieved when the attack disappeared, effective when the attack frequency decreased more than 50%, invalid when the attack frequency decreased less than or equal to 50%.
次要结局
- Status of depression(At 12th week)