A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression: a Muli-center, Randomized, Double-blinded, Placebo-controlled Superiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 9
- 主要终点
- symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
The main purpose of this study is to determine the effects of add-on therapy of wuling capsule on depressive symptoms in patients with comorbidity of epilepsy and depression, to evaluate its influences on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life.
详细描述
The phenomenon of epileptic patients who have psychiatric disorders is very common, of which the prevalence of depression is the highest and depression is also an independent risk factor affecting epileptic patients' quality of life. Due to some social factors, non-typical clinical symptoms and limited therapeutic methods(tricyclic antidepressants, lithium chloride and 5-serotonin uptake inhibitors may all have risks of lowing threshold of seizures), epileptic patients with depression are usually not be recognized and treated properly. Wuling capsule has been used in therapy of insomnia, nervous breakdowns and a previous small sample clinical trial revealed that it could improve mood disorders of epileptic patients and hadn't affected severity of seizures (not published). Therefore a multi-center, randomized, double-blinded and placebo-controlled superiority clinical trial will be carried out to determine the effects of add-on therapy of wuling capsule on depressive symptoms in patients with epilepsy, to evaluate its influences on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects for this study will meet the following criteria:
- •Age greater than or equal to 18 years.
- •Must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. The duration to the latest seizure must be longer than 24 hours.
- •Score of a 17 item Hamilton Depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks.
- •Haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks.
- •Must sign the informed consent form.
排除标准
- •Now accepting or have accepted other drugs clinical trial in the last month.
- •History of serious psychiatric illness other than depression.
- •Having suicide ideas or suicide behaviors.
- •Progressive illness of central nervous system, such as degenerative disease or tumor.
- •History of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors.
- •The value of ALT or AST is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul.
- •During pregnant or lactation period.
- •The person who is disabled or mentally disabled.
研究组 & 干预措施
Wuling capsule
干预措施: wuling capsule (Drug)
Placebo
干预措施: placebo of wuling capsule (Drug)
结局指标
主要结局
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)
时间窗: 3 months
次要结局
- the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)(3 months)
- the frequency of seizures using diary(3 months)
- the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)(3 months)
- the quality of life using Quality of Life in Epilepsy (QOLIE-31)(3 months)
研究者
Weifeng Peng
neurology department
Shanghai Zhongshan Hospital