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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
orally, three tablets each time,three times a day
orally, three tablets each time and three times a day
Peking Union Medical College Hospital, Beijing, China
Beijing, Beijing Municipality, China
the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
Guangzhou, Guangdong, China
Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality, China
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)
Time frame: 3 months
the frequency of seizures using diary
Time frame: 3 months
the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)
Time frame: 3 months
the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
the quality of life using Quality of Life in Epilepsy (QOLIE-31)
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, China
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, China
Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
Shanghai, Shanghai Municipality, China
the Sixth People's Hospital of Shanghai Jiaotong University,Shanghai,China
Shanghai, Shanghai Municipality, China
Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
the First Municipal Hospital of Guangzhou
Guangzhou, China